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Last update 07 Jun 2025

Prizloncabtagene autoleucel

Last update 07 Jun 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

Anti-CD19 anti-CD20 bispecific chimeric antigen receptor T cell therapy - Cellular Biomedicine Group, CD19/CD20-directed CAR-T cells, C CAR039

+ [6]

Target

CD19 x CD20

Action

inhibitors

Mechanism

CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Diffuse Large B-Cell LymphomaMediastinal large B-cell lymphomaNon-Hodgkin Lymphoma+ [4]

Inactive Indication

B-cell lymphoma refractory

Originator Organization

AbelZeta Pharma, Inc.

Active Organization

Janssen Biotech, Inc.

Johnson & Johnson

Shanghai Cellular Biopharmaceutical Group Ltd.

Inactive Organization

AbelZeta Pharma, Inc.

Peking University

License Organization

Janssen Biotech, Inc.

AbelZeta Pharma, Inc.

Drug Highest PhasePhase 1/2

First Approval Date-

RegulationFast Track (United States), Orphan Drug (United States), Regenerative Medicine Advanced Therapy (United States)

Structure/Sequence

Sequence Code 801710067

Clinical Trials associated with Prizloncabtagene autoleucel

CTR20250125

/ RecruitingNot Applicable

抗CD19/CD20嵌合抗原受体自体T细胞注射液（C-CAR039）治疗CD19或CD20阳性的复发或难治性大B细胞淋巴瘤的Ib/II期临床研究长期随访研究

[Translation] Long-term follow-up study of a phase Ib/II clinical study of anti-CD19/CD20 chimeric antigen receptor autologous T cell injection (C-CAR039) in the treatment of CD19 or CD20 positive relapsed or refractory large B-cell lymphoma

1)评价C-CAR039治疗复发或难治性大B细胞淋巴瘤（LBCL）受试者的长期安全性；2)评价C-CAR039治疗复发或难治性LBCL受试者的长期生存情况；3）评价C-CAR039细胞制剂长期的药代动力学；4）评价C-CAR039治疗复发或难治性LBCL受试者的长期免疫原性；5）评价C-CAR039治疗复发或难治性LBCL受试者的长期疗效（入组时处于缓解状态的受试者）。

[Translation]

1) Evaluate the long-term safety of C-CAR039 in the treatment of subjects with relapsed or refractory large B-cell lymphoma (LBCL); 2) Evaluate the long-term survival of subjects with relapsed or refractory LBCL treated with C-CAR039; 3) Evaluate the long-term pharmacokinetics of C-CAR039 cell preparations; 4) Evaluate the long-term immunogenicity of C-CAR039 in the treatment of subjects with relapsed or refractory LBCL; 5) Evaluate the long-term efficacy of C-CAR039 in the treatment of subjects with relapsed or refractory LBCL (subjects in remission at the time of enrollment).

Start Date21 Jun 2023

Sponsor / Collaborator

Shanghai Cellular Biopharmaceutical Group Ltd.

NCT05800977

/ RecruitingPhase 1/2

A Phase 1b/2 Study of a Anti-CD19/CD20 Bispecific CAR-T Therapy (C-CAR039/Prizloncabtagene Autoleucel) in Patients with Relapsed/Refractory Large B-Cell Lymphoma

This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).

Start Date22 Feb 2023

Sponsor / Collaborator

Shanghai Cellular Biopharmaceutical Group Ltd.

NCT05149391

/ Unknown statusPhase 1IIT

A Phase 1 Study of CD19 and CD20 Targeted Chimeric Antigen Receptor T Cells Therapy (C-CAR039) in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma

This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B cell Non-Hodgkin's Lymphoma patients.

Start Date20 Jul 2021

Sponsor / Collaborator

Peking University

100 Clinical Results associated with Prizloncabtagene autoleucel

100 Translational Medicine associated with Prizloncabtagene autoleucel

100 Patents (Medical) associated with Prizloncabtagene autoleucel

Literatures (Medical) associated with Prizloncabtagene autoleucel

03 Apr 2025·BLOOD

A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma

Article

Author: Yang, Min ; Yao, Yihong ; Zhang, Yan ; Yao, Xin ; Ye, Shiguang ; Lan, Liping ; Zhao, Jing ; Zhou, Lili ; Zheng, Chengxiao ; Li, Lanfang ; Zhu, Kevin ; Wan, Hui ; Li, Jing ; Zhu, Dan ; Liang, Aibin ; Yu, Wenjuan ; Zhang, Huilai ; Zhou, Daobin ; Li, Ping ; Huang, Jiaqi ; Jin, Jie

Abstract:

Prizloncabtagene autoleucel (prizlon-cel), a novel bispecific chimeric antigen receptor T cell, targets and eliminates CD19/CD20-positive tumor cells. This phase 1, open-label study investigated the safety and efficacy of prizlon-cel in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). Patients with CD19 and/or CD20-positive R/R B-NHL received a 3-day lymphodepletion (cyclophosphamide: 300 mg/m2 per day; fludarabine: 30 mg/m2 per day) followed by an IV dose of prizlon-cel. The primary end points were dose-limiting toxicity (DLT) and incidence and severity of treatment-emergent adverse events (TEAEs). Secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Of the 48 patients infused prizlon-cel, 44 had large B-cell lymphoma (LBCL). No patient experienced DLT. Cytokine release syndrome occurred in 93.8% of the patients, with only 1 case of grade 3. Immune effector cell-associated neurotoxicity syndrome occurred in 6.3% of patients, with no grade 3 or higher events. The most common grade 3 or higher TEAEs were neutropenia (83.3%) and leukopenia (50%). The ORR and complete response (CR) rates in all patients were 91.5% and 85.1%, respectively, and in LBCL patients, ORR was 90.7% with 86.0% CR. With median follow-up of 30.0 months, median DOR, PFS, and OS were all not reached. Kaplan-Meier estimate of 2-year DOR, PFS, and OS rates were 66.0%, 62.6%, and 76.5%, respectively. Prizlon-cel had a favorable safety profile and a high and durable response in patients with R/R B-NHL, suggesting a promising treatment option for patients with R/R B-NHL. These trials were registered at www.clinicaltrials.gov as #NCT04317885, #NCT04655677, #NCT04696432, and #NCT04693676.

03 Apr 2025·BLOOD

Prizloncabtagene autoleucel: a new CAR T cell for B-NHL

Communications

Author: Sureda, Anna ; Mussetti, Alberto

News (Medical) associated with Prizloncabtagene autoleucel

28 Nov 2024

·www.prnewswire.com

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyLicense out/inPhase 3VaccineCell Therapy

14 Dec 2023

·www.prnewswire.com

AbelZeta Announces Amendment to Worldwide Collaboration and License Agreement with Janssen to Include China

Amended worldwide collaboration and license agreement for CD20-directed chimeric antigen receptor T (CAR-T) C-CAR039 and C-CAR066 to include an option for commercialization of products in China ROCKVILLE, Md. and SHANGHAI, Dec. 14, 2023 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced an amendment of its worldwide collaboration and license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company. Under the amended agreement, Janssen will have the option to obtain exclusive commercialization rights in China for CD20-directed chimeric antigen receptor T (CAR-T) C-CAR039 and C-CAR066, which are being studied for the treatment of Non-Hodgkin Lymphoma (NHL). Continue Reading "As presented recently at the 65th ASH Annual Meeting, the clinical data for both C-CAR039 and C-CAR066 continue to support the potential of both assets to be best in disease in relapsed or refractory (r/r) NHL," said Tony (Bizuo) Liu, Chairman and CEO of the Company. "The Centre for Drug Evaluation in China has approved the Investigational New Drug (IND) application for C-CAR039, and we are currently conducting the Phase 1b study. We are excited to leverage AbelZeta's clinical development and product manufacturing capabilities together with Janssen's global commercialization expertise to maximize the potential of C-CAR039 and C-CAR066 to bring innovative and life-changing therapies to patients in China and worldwide." "The clinical data continues to support the potential of both assets to be best in disease in r/r NHL." Post this Under the terms of the agreement, Janssen will pay AbelZeta Pharma an option exercise fee, and AbelZeta Pharma is eligible to receive commercialization and sales milestones. About the Studies C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, and Regenerative Medicine Advanced Therapy and Fast Track designations for the treatment of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). A Phase 1b study in the U.S. evaluating C-CAR039 in the treatment of patients with r/r DLBCL is underway. C-CAR066 is an optimized, novel CD20 targeted CAR-T therapy that has also received U.S. FDA IND clearance, and a Phase 1b study in patients with r/r DLBCL, including r/r to CD19 CAR-T treatment, is underway in the U.S. About NHL and DLBCL Non-Hodgkin Lymphoma (NHL) is the most common hematological, or blood malignancy worldwide. NHL ranked as the 5th to 9th most common cancer in most countries globally, with an estimated 544,000 new cancer cases and 260,000 cancer deaths in 2020.1 Diffuse large B-cell lymphoma (DLBCL) is a common and aggressive form of non-Hodgkin lymphoma that accounts for one out of every three cases of NHL. Despite available frontline treatment, many patients will experience a relapse or have refractory (resistant to treatment) disease, for which there are limited treatment options and a high risk of mortality. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.2,3 Mafra A, Laversanne M, Gospodarowicz M, Klinger P, De Paula Silva N, Piñeros M, Steliarova-Foucher E, Bray F, Znaor A. Global patterns of non-Hodgkin lymphoma in 2020. Int J Cancer. 2022 Nov 1;151(9):1474-1481. doi: 10.1002/ijc.34163. Epub 2022 Jul 2. PMID: 35695282. Crump M, Neelapu SS, Farooq U et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017; 130(16): 1800-1808. Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Can. 2014; 3(1): 66-70. About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact: Sarah Kelly Director of Communications AbelZeta Pharma, Inc. +1 (240) 552 5870 [email protected] SOURCE AbelZeta Pharma, Inc.

License out/inPhase 1ImmunotherapyCell TherapyFast Track

12 Dec 2023

·www.prnewswire.com

AbelZeta Presents Data from Two Clinical Studies Relating to its Immuno-Oncology Drug Development at the 65th ASH Annual Meeting

C-CAR039 study at median follow up of 30.0 months demonstrated a 91.5% overall response rate and an 85.1% complete response rate among evaluable patients with r/r NHL C-CAR066 study at median follow up of 27.7 months demonstrated a 92.9% overall response rate and a 57.1% complete response rate among evaluable patients with LBCL who failed prior CD19 CAR-T therapy ROCKVILLE, Md., Dec. 12, 2023 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, presented clinical data for both C-CAR039 for the treatment of patients with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL), and C-CAR066, for the treatment of patients with r/r large B-cell lymphoma (LBCL) who failed prior CD19 CAR-T therapy at the 65th American Society of Hematology (ASH) Annual Meeting. Continue Reading "We are thrilled to share the long-term follow-up results from our clinical studies of C-CAR039 and C-CAR066 at the Annual Meeting of ASH, said Tony (Bizuo) Liu, Chairman and CEO of the Company. "The positive outcomes underscore the potential of these novel therapies in advancing the treatment landscape for patients with r/r B-NHL. The observed response rates, durability, and manageable safety profile demonstrated in both studies reinforce our commitment to pioneering innovative and effective solutions in immuno-oncology for patients suffering from serious hematological malignancies." "The positive outcomes underscore the potential of these novel therapies in advancing treatment for patients with B-NHL" Post this "We are proud of our collaboration and license agreement with Janssen to facilitate the global development and accessibility of C-CAR039 and C-CAR066. This strategic partnership aligns with our mission to bring innovative and life-changing therapies to patients worldwide." In May 2023, AbelZeta Pharma (formerly CBMG) entered into a global collaboration and license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, for C-CAR039, an anti-CD19 & CD20 bi-specific CAR-T therapy, and C-CAR066, an anti-CD20 CAR-T. Study Conclusions At a longer median follow-up of 30.0 months, C-CAR039 demonstrated a favorable safety profile with deep and durable response in patients with r/r B-NHL, especially in LBCL patients. Longer term follow-up demonstrated that C-CAR066 can produce a deep and durable response with a favorable safety profile in patients with r/r LBCL who failed prior CD19 CAR-T therapy. About the C-CAR039 Study C-CAR039 has been developed as a novel 2nd generation 4-1BB bi-specific CAR-T targeting both CD19 and CD20 antigens with an optimized bi-specific antigen binding domain. C-CAR039 has consistently shown ability to eradicate CD19/CD20 single or double positive tumor cells in vitro and in vivo. GMP manufacturing of C-CAR039 was carried out in a serum free and fully closed semi-automatic system. In the Phase I clinical trials in China (NCT04317885, NCT04655677, NCT04696432, NCT04693676), dose escalation and expansion studies were conducted to evaluate the safety and efficacy of C-CAR039 in r/r B-NHL patients. C-CAR039 was administered as a single intravenous dose after a 3-day cyclophosphamide (300mg/m2x3d) plus fludarabine (30mg/m2x3d) conditioning regimen. Key Results of C-CAR039 Between November 5, 2019, and January 11, 2022, 48 patients received C-CAR039 at the dose ranges of 1.0 x 106 to 5.0x106 CAR-T cells/kg. Of the 48 patients, 44 (91.7%) patients had large B-cell lymphoma (LBCL) (DLBCL, n=37; PMBCL, n=3; tFL, n=4), 3 patients had FL and 1 patient had MCL. The median age was 55 (range, 25-71) years, and 11 (22.9%) patients were ≥ 65 years. Thirty-six (75%) patients were in Ann Arbor Stage III/IV with 3 median prior lines of therapy, 32 (66.7%) patients were refractory to their last treatment, and 22 (45.8%) patients never achieved CR to their prior therapies. As of September 25, 2023, 45 patients (93.8%) experienced CRS, only 1 (2.1%) were grade 3. Three patients had grade 1 or 2 ICANS at a dose of 5.0x106 CAR-T cells/kg. Grade 3 or higher cytopenia not resolved by Day 30 following C-CAR039 infusion included neutropenia (54.2%), thrombocytopenia (20.8%), and anemia (20.8%). At cutoff date, 66.7% patients had infections with 25% grade 3 or higher. Second primary malignancy after C-CAR039 infusion was observed in 3 patients and none were related to C-CAR039. Fifteen deaths occurred, 11 due to disease progression. Of the 48 patients, 47 patients were evaluable for efficacy. The median follow-up time was 30.0 months. The ORR and CR rate among evaluable patients were 91.5% and 85.1% respectively. Of the 43 LBCL patients, the ORR was 90.7%, with 86.0% CR. Median duration of response (DOR) was not reached. 23/47 (48.9%) patients remain in CR, 10 of them for more than 36 months. Median PFS has not been reached. KM estimates of 24-m PFS rate were 62.6% (all patients) and 64.1% (LBCL). Median OS has not been reached. KM estimates of 24-m OS rate were 76.5% (all patients) and 79.0% (LBCL). The complete text of the abstract can be found About the C-CAR066 Study C-CAR066 is a novel second generation CAR-T therapy targeting the CD20 antigen. Preclinical studies suggest that C-CAR066 has superior anti-tumor activity compared to anti-CD20 CAR-Ts derived from scFVs of Leu16, Rituximab and Obinutuzumab, and to anti-CD19 CAR-Ts derived from scFV FMC63. The Phase I clinical trials (NCT04036019, NCT04316624) were conducted in Shanghai Tongji Hospital and Institute of Hematology & Blood Diseases Hospital in Tianjin, China, to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B-NHL who were previously treated with and failed after an anti-CD19 CAR-T therapy. C-CAR066 was administered as a single intravenous dose after a 3-day cyclophosphamide (300mg/m2x3d) plus fludarabine (30mg/m2x3d) conditioning regimen. Key Results of C-CAR066 Between October 16, 2019, and August 17, 2021, a total of 14 patients received C-CAR066 at doses of 2.0x106 CAR-T cells/kg and 3.0x106 CAR-T cells/kg. Eleven patients (78.6%) were DLBCL, 3 patients (21.4%) were tFL. The median age was 54.5 years (range, 37-67). Twelve patients (85.7%) were in Ann Arbor Stage III/IV. The median number of prior lines of therapy was 5 (range, 2-7). All patients had prior CD19 CAR-T therapy. As of October 10, 2023, 12/14 patients (85.7%) experienced CRS, all were grade 1/2, except for 1 patient who experienced a grade 4 CRS. No patients experienced ICANS. Grade 3 or higher cytopenia not resolved by Day 30 following C-CAR066 infusion occurred in 28.6% patients and included neutropenia (21.4%), thrombocytopenia (14.3%), and anemia (14.3%). At cutoff date, 8 patients experienced infections, only 2 were grade 3. Seven deaths occurred and all due to disease progression. No SPM and new safety signals were observed with longer follow-up. The investigator assessed ORR was 92.9%, with 57.1% CR. With the median follow-up of 27.7 months, median PFS and DOR were 9.4 months and 8.3 months, respectively. Four patients had remained in CR for more than 30 months. The Kaplan-Meier estimate of median OS was 34.8 months (11.4 - NA). The complete text of the abstract can be found About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact: Sarah Kelly Director of Communications AbelZeta Pharma, Inc. Phone: +1 (240) 552 5870 Email: [email protected] SOURCE AbelZeta Pharma, Inc.

Clinical ResultPhase 1License out/inImmunotherapyCell Therapy

100 Deals associated with Prizloncabtagene autoleucel

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	Phase 2	China	Shanghai Cellular Biopharmaceutical Group Ltd.	22 Feb 2023
Mediastinal large B-cell lymphoma	Phase 2	China	Shanghai Cellular Biopharmaceutical Group Ltd.	22 Feb 2023
Non-Hodgkin Lymphoma	Phase 1	United States	AbelZeta Pharma, Inc.	14 Dec 2021
B-cell lymphoma refractory	Phase 1	China	Peking University	20 Jul 2021
Hodgkin's Lymphoma	Phase 1	China	Shanghai Cellular Biopharmaceutical Group Ltd.	30 Oct 2020
CD19 positive B-Cell Lymphoma	Phase 1	China	Shanghai Cellular Biopharmaceutical Group Ltd.	03 Aug 2020
Hematologic Neoplasms	Phase 1	United States	Johnson & Johnson	-
CD20 positive Large B-cell lymphoma	Clinical	China	Shanghai Cellular Biopharmaceutical Group Ltd.	21 Jun 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04693676 \| NCT04655677 \| NCT04317885 \| NCT04696432 (Pubmed) Manual	Phase 1	Non-Hodgkin Lymphoma CD20 Positive \| CD19 Positive	48	Prizloncabtagene autoleucel	uezirieuqt(itchanotvj) = hmvuoarxwo klrlxztrfj (efyoaqbamv ) View more	Positive	15 Jan 2025
	Phase 1	Non-Hodgkin Lymphoma CD20 Positive \| CD19 Positive	48	Prizloncabtagene autoleucel (Large B-cell lymphoma (LBCL))	szmfxlrsaf(qeynqgwjmp) = xfrvnhbzqh lbgdhcnxwb (bsrrlyxcyo ) View more	Positive	15 Jan 2025
NCT04693676 \| NCT04655677 \| NCT04317885 \| NCT04696432 (C-CAR039, EHA2024)	Phase 1	B-cell lymphoma refractory CD20 \| CD19	48	C-CAR039	pkstikzbfd(lkydzugmuo) = nveymdgtio tyxjlkzstr (xizqfdmarx ) View more	Positive	14 May 2024
CTR20250125 (ASH2023) Manual	Not Applicable	B-Cell Lymphoma	48	C-CAR039	deabjxgxwp(uxyzelwxjk) = mfvpeddnbc pybxdwocuf (yplrudcgfl ) View more	Positive	11 Dec 2023
NCT04317885 (ASCO2021)	Phase 1	B-cell lymphoma refractory	28	C-CAR039	ctfwmvpsxx(hhxbbxbcfp) = pwqxtokvut zcvwolrshs (vmorjmuhai ) View more	-	28 May 2021
NCT04317885 (ASH 12020 \| ASH 22020) Manual	Phase 1	B-Cell Lymphoma	16	cyclophosphamide+fludarabine+C-CAR039	mhtkjaetjz(edhiuhvzph) = Reversible CRS was observed in 12 (86%) of patients plkcbbcdge (hzmxusbszo ) View more	Positive	05 Nov 2020

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