CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), PD-1 inhibitors(Programmed cell death protein 1 inhibitors), TIGIT inhibitors(T cell immunoglobulin and ITIM domains inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [3]

Active Indication

Diffuse large B-cell lymphoma recurrentPrimary mediastinal large B-cell lymphoma recurrentDiffuse Large B-Cell Lymphoma+ [6]

Inactive Indication-

Originator Organization

Curocell, Inc.

Active Organization

Curocell, Inc.

Asan Medical Center

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

South Korea (29 Apr 2026),

Diffuse Large B-Cell LymphomaMediastinal large B-cell lymphoma

Regulation-

Structure/Sequence

Sequence Code 1277314194

Source: *****

Clinical Trials associated with Anbalcabtagene autoleucel

NCT07364396

/ Not yet recruitingPhase 1/2

An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus

The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE).
The main objectives of the study are:
1. To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis.
2. To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity.
Study Design This is a single-arm, open-label, multi-center, Phase 1/2 study. All enrolled participants will receive CRC01 after screening and baseline assessments.
Study Procedures
Participants will:
* Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments.
* Provide autologous T lymphocytes through a procedure called leukapheresis.
* Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy).
* Receive a single intravenous infusion of CRC01 cells.
* Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity.
* Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response.
Key Outcomes
Researchers will measure:
* Changes in proteinuria and kidney function.
* Changes in disease activity scores.
* Incidence and severity of adverse events.

Start Date01 Feb 2026

Sponsor / Collaborator

Curocell, Inc.

NCT07062627

/ RecruitingPhase 2IIT

A Pilot Study of Anbalcabtagene Autoleucel in Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma

This clinical study aims to evaluate the tolerability, safety, and efficacy of Anbal-cel in patients with recurrent or refractory PCNSL or SCNSL.
Subjects who have provided written consent and meet the inclusion and exclusion criteria through screening evaluations will undergo leukapheresis (LP) for Anbal-cel manufacturing. Subjects whose collected nucleated cells are confirmed suitable for Anbal-cel production will be enrolled in the clinical study.
Prior to Anbal-cel administration, lymphodepletion therapy will be performed and must be completed at least 2 days before Anbal-cel administration. Anbal-cel will be administered to subjects who meet the inclusion and exclusion criteria for Anbal-cel administration.
Study subjects will be hospitalized for a minimum of 7 days to closely monitor adverse events and receive prompt necessary treatment after Anbal-cel administration. All study subjects will undergo primary visit evaluations for 12 months following Anbal-cel administration.
Subjects who discontinue primary visit evaluations before the 12-month visit will undergo an end of study 1 (EOS1) visit for safety observation. For subjects whose primary visit evaluations end before the 12-month visit due to disease progression (PD), withdrawal of consent for primary visit evaluations, or subsequent anti-cancer therapy, secondary follow-up visits will be conducted from the EOS1 visit to the 12-month time point (EOS2). The timing of the first secondary follow-up visit will be determined based on when the subject's primary visit evaluation was discontinued.
A separate long-term follow-up study is planned to monitor long-term safety, including delayed adverse events (AEs), in subjects who received Anbal-cel. In this long-term follow-up study, each subject will be followed for 15 years from the date of Anbal-cel administration. All specific details, including the visit schedule and examination items for the long-term follow-up study, will be described in a separate protocol.

Start Date12 Nov 2025

Sponsor / Collaborator

Asan Medical Center

[+1]

NCT04836507

/ RecruitingPhase 1/2

An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma

This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma.

Start Date02 Mar 2021

Sponsor / Collaborator

Curocell, Inc.

100 Clinical Results associated with Anbalcabtagene autoleucel

100 Translational Medicine associated with Anbalcabtagene autoleucel

100 Patents (Medical) associated with Anbalcabtagene autoleucel

Literatures (Medical) associated with Anbalcabtagene autoleucel

01 Jun 2023·HEMATOLOGICAL ONCOLOGY

PHASE 2 STUDY OF ANBAL‐CEL, NOVEL ANTI‐CD19 CAR‐T THERAPY WITH DUAL SILENCING OF PD‐1 AND TIGIT IN RELAPSED OR REFRACTORY LARGE B CELL LYMPHOMA ‐ INTERIM ANALYSIS RESULT

Article

Author: Jung, J. ; Yoon, S. E. ; Yoon, S. ; Lee, H. ; Kim, J. ; Kim, S. J. ; Kim, W. ; Koh, Y. ; Eom, H. ; Yoon, D. H. ; Yang, D. ; Cho, H.

Introduction: Anbal-cel is a novel autologous anti-CD19 CAR-T cell therapy which has been knocked-down for PD-1 and TIGIT expression using OVIS platform. It demonstrated superior T-cell functionality compared to other marketed CD19 CAR-T cells at preclinical studies. Phase 1 dose escalation study confirmed anbal-cel is safe and potentially effective. Methods: Patients with relapsed or refractory LBCL were enrolled from six Korean investigator sites to receive anbal-cel at a dose of 2 × 106 CAR-T cells/kg. Primary endpoint is objective response rate (ORR) assessed by Independent Review Committee (IRC). Secondary endpoints are progression-free survival (PFS), duration of response (DOR), pharmacokinetics (PK) and safety profiles. Results: As of 28 February 2023, a total of 41 patients were infused and 34 patients completed at least one tumor response evaluation at day 28. With the median age of 63 (range 37–82), 66% of the patients (27/41) were double expressor. Non-GCB type was 76% (31/41) and 42% (17/41) were primary refractory patients. Median follow-up period was 4.6 months. ORR (CR/PR) assessed by investigators was 85.3% and CR rate at day 28 & month 3 were 73.5% (25/34) and 71.4% (22/31) respectively. IRC assessment result was similar and will be presented at the meeting. Among the 41 patients, grade 3 CRS and ICANS were reported from 6 patients (14.6%) and 2 patients (4.9%) respectively. No grade 4 CRS and ICANS was observed. Prolonged neutropenia was observed in 11 patients (26.8%) and thrombocytopenia was observed in 12 patients (29.3%). Three (7.3%) serious infections (1 bacteria and 2 COVID-19 infections) were reported during primary follow-up period. Responder group (CR) reported higher incidence and severity of CRS compared to non-responder group (Non-CR), but it was insignificant. Incidence rate, severity of ICANS and prolonged cytopenia were comparable between the two groups. Among CAR+ T-cells in the anbal-cel product, median CD4:CD8 ratio was 3.6 and CCR7+ memory phenotype CAR T-cells account for 65.8% of CAR-T cells. Median knock-down rates of PD-1 and TIGIT were 65% and 96% respectively. The responder group showed a significantly increased level of CCR7+ memory phenotype (68.6% vs. 44.9%) and PD-1 knock-down rate (71.8% vs. 59.3%) compared to the non-responder group, which showed correlation with increased levels of AUC0-28days and Cmax. Anbal-cel expansion was not correlated to tumor volume measured by SPD and TMTV. In addition, the responder group had notable changes in cytokine levels of IL-2, IL-10, IFN-γ, granzyme, GM-CSF and peak levels of various cytokines were proportional to severity of CRS. Patients with higher levels of IL-15 and MCP-1 at baseline had tendency to experience ICANS. Conclusions: Anbal-cel demonstrated unique characteristics in product profile which demonstrated potential to correlate with treatment outcomes and warrant to confirm with more data. The research was funded by: Curocell Inc. Keywords: aggressive B-cell non-Hodgkin lymphoma, cellular therapies, immunotherapy No conflicts of interests pertinent to the abstract.

01 Jun 2021·The Lancet. OncologyQ1 · MEDICINE

Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial

Q1 · MEDICINE

Article

Author: Eriko Yamamoto ; Kanwal Raghav ; Fortunato Ciardiello ; Javier Rodriguez ; Tomohiro Nishina ; Kensei Yamaguchi ; Destiny-Crc investigators ; Fotios Loupakis ; Javad Shahidi ; Hisato Kawakami ; Ki Chung ; Toshiki Masuishi ; Andrea Sartore-Bianchi ; Yoshito Komatsu ; Yasuyuki Okuda ; Maria Di Bartolomeo ; Elena Elez ; Axel Grothey ; Marwan Fakih ; Taito Esaki ; Salvatore Siena ; Takayuki Yoshino ; Kapil Saxena ; Zev Wainberg ; Emarjola Bako

BACKGROUND:

HER2 amplification has been identified in 2-3% of patients with colorectal cancer, although there are currently no approved HER2-targeted therapies for colorectal cancer. We aimed to study the antitumour activity and safety of trastuzumab deruxtecan (an antibody-drug conjugate of humanised anti-HER2 antibody with topoisomerase I inhibitor payloads) in patients with HER2-expressing metastatic colorectal cancer.

METHODS:

DESTINY-CRC01 is an open-label, phase 2 study that recruited patients from 25 clinics and hospitals in Italy, Japan, Spain, the UK, and the USA. Eligible patients had centrally confirmed HER2-expressing metastatic colorectal cancer that had progressed on two or more previous regimens (HER2-targeted therapies other than trastuzumab deruxtecan permitted), were aged 18 years or older (≥20 years in Japan), had an Eastern Cooperative Oncology Group score of 0 or 1, and had RAS and BRAF^V600E wild-type tumours. Patients were enrolled into one of three cohorts by HER2 expression level: cohort A (HER2-positive, immunohistochemistry [IHC] 3+ or IHC2+ and in-situ hybridisation [ISH]-positive), cohort B (IHC2+ and ISH-negative), or cohort C (IHC1+). Patients received 6·4 mg/kg trastuzumab deruxtecan intravenously every 3 weeks until disease progression, unacceptable adverse events, withdrawal of consent, or death. The primary endpoint was confirmed objective response rate in cohort A by independent central review which was assessed in the full analysis set and safety was assessed in the safety analysis set. Both the full analysis set and the safety analysis set included all patients who received one or more doses of trastuzumab deruxtecan. This ongoing trial is registered with ClinicalTrials.gov, number NCT03384940.

FINDINGS:

Between Feb 23, 2018, and July 3, 2019, 78 patients were enrolled in the study (53 in cohort A, seven in cohort B, and 18 in cohort C), all of whom received at least one dose of study drug. For the 53 (68%) patients with HER2-positive tumours (cohort A), a confirmed objective response was reported in 24 (45·3%, 95% CI 31·6-59·6) patients after a median follow-up of 27·1 weeks (IQR 19·3-40·1). Grade 3 or worse treatment-emergent adverse events that occurred in at least 10% of all participants were decreased neutrophil count (17 [22%] of 78) and anaemia (11 [14%]). Five patients (6%) had adjudicated interstitial lung disease or pneumonitis (two grade 2; one grade 3; two grade 5, the only treatment-related deaths).

INTERPRETATION:

Trastuzumab deruxtecan showed promising and durable activity in HER2-positive metastatic colorectal cancer refractory to standard treatment, with a safety profile consistent with that reported in previous trastuzumab deruxtecan trials. Interstitial lung disease and pneumonitis are important risks requiring careful monitoring and prompt intervention.

FUNDING:

Daiichi Sankyo.

Cancer Research and Treatment

Comparative Effectiveness of Anbalcabtagene Autoleucel versus Tisagenlecleucel in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma

Article

Author: Kim, Ji Won ; Seo, Hee-Jin ; Jung, Kyungyeon ; Kim, Won Seog ; Yoo, Woo Hyeon ; Shin, Ju-Young ; Kim, Ju Hwan

Purpose:

Anbalcabtagene autoleucel (anbal-cel) is a second-generation CD19-targeted chimeric antigen receptor-T cell therapy reducing T-cell exhaustion through PD-1 and TIGIT downregulation. We compared efficacy of anbal-cel with tisagenlecleucel (tisa-cel) in relapsed/refractory diffuse large B-cell lymphoma using external control arm study design.

Materials and Methods:

We performed a matching-adjusted indirect comparison (MAIC) using individual patient data from CRC01-01 (NCT#04836507) and aggregate data from JULIET trial (NCT#02445248). Primary outcomes were overall survival (OS) and progression free-survival (PFS), with corresponding hazard ratio (HR) and 95% confidence interval (CI) assessed using weighted Cox proportional hazard model. Secondary outcomes were objective response rate (ORR) and complete response rate (CRR), with corresponding odds ratio (OR) and 95% CI assessed using weighted logistic regression model.

Results:

We included 79 patients in CRC01-01 and 115 in JULIET trial. In naïve comparison, median OS was not reached (NR; 95% CI 13.1-NE) for anbal-cel versus 11.1 months (6.6-23.9) for tisa-cel, corresponding to HR of 0.54 (0.34-0.87). Median PFS was 5.5 months (4.2-16.2) versus 2.9 months (2.3-5.2) with HR of 0.73 (0.50-1.08). ORR was 73.4% versus 53.0% with OR of 2.45 (1.32-4.54), and CRR was 64.6% versus 39.1% with OR of 2.83 (1.56-5.13). After applying MAIC to balance prognostic factors between the groups, adjusted HRs or ORs were 0.47 (0.23-0.95) for OS, 0.59 (0.36-0.96) for PFS, 2.60 (1.04-6.52) for ORR, and 3.00 (1.30-6.92) for CRR.

Conclusion:

Anbal-cel showed superior effectiveness over tisa-cel, with higher response rates and improved survival outcomes, even after accounting for imbalances in prognostic factors at trial enrollment.

News (Medical) associated with Anbalcabtagene autoleucel

30 Apr 2026

·www.biospace.com

Curocell’s RIMQARTO Inj. Wins Full Regulatory Approval, Poised to Enter CAR-T Market with 67% Complete Response Rate

Secured formal approval from local authorities instead of conditional approval, demonstrating the competitiveness of the CAR T-cell therapy RIMQARTO ® marks Korea’s first commercialization of CAR T-cell therapy and 42nd domestically developed drug The approval marks a key step in the push for global expansion, thanks to expedited review and inter-agency coordination SEOUL, South Korea--(BUSINESS WIRE)-- #AutologousCellTherapy -- Curocell (KOSDAQ: 372320) said that RIMQARTO® Inj. (anbalcabtagene autoleucel), South Korea’s first domestically developed CAR T-cell therapy, has secured full regulatory approval from the Ministry of Food and Drug Safety (MFDS) on April 29. With this approval, RIMQARTO® becomes the 42 nd drug domestically developed under the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products for manufacture and sale. This represents the first commercialization of CAR T-cell therapy by a Korean company. The CAR T-cell therapy is a personalized autologous T-cell immunotherapy in which a patient’s immune cells are genetically modified to selectively target cancer cells. RIMQARTO® has drawn attention as a next-generation CD19 CAR T-cell therapy powered by Curocell’s proprietary OVIS™ (Overcome Immune Suppression) technology. This technology is designed to regulate immunosuppressive signals in the tumor microenvironment, addressing “T-cell exhaustion,” and enabling more sustained anticancer activity over the long term. RIMQARTO® is indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adults following two or more lines of systemic therapy. In the pivotal Phase 2 trial supporting the approval, RIMQARTO® achieved an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%. The therapy also showed its safety profile, with cytokine release syndrome (CRS), a key adverse event associated with CAR T-cell therapy, reported in 10% of patients, and immune effector cell-associated neurotoxicity syndrome (ICANS) reported in 5%. Although RIMQARTO® was initially submitted for conditional approval, the MFDS waived the requirement for Phase 3 trial data during the review process, taking into account its use as a third-line treatment for lymphoma and its classification as a novel CAR T-cell therapy. As with other global CAR T-cell therapies, the approval is subject to long-term follow-up studies and risk management plans to monitor the therapy’s safety and efficacy. The approval reflects the combined impact of the MFDS’s expedited review framework and full-cycle support from government R&D programs. RIMQARTO® was developed with support from the Ministry of Health and Welfare (MOHW) R&D program and the Korea Drug Development Fund . In addition, the MFDS’s “Bio-Challenger Program” for advanced biopharmaceuticals and RIMQARTO®’s “Global Innovative Products on Fast Track” (GIFT) and fast-track processing designations enhanced both efficiency and speed throughout the development and approval review processes. RIMQARTO® was also selected for the MOHW’s “Concurrent Pilot Program for Approval-Evaluation-Negotiation,” which is expected to shorten the timeline from its approval to national health insurance reimbursement listing. Curocell CEO Kim Gun-soo said, “The latest approval is a milestone in Korea’s new drug development history. We would like to express our gratitude to everyone who has worked tirelessly to make this achievement possible. We have been researching because CAR T-cell technology was not available in Korea. We have now secured our first new drug approval. With the capabilities and experience accumulated so far, we are committed to advancing the global success of Korea’s CAR-T technology.” Building on RIMQARTO®, Curocell plans to pursue indication expansion, global market entry, and the development of next-generation pipelines, while further demonstrating the scalability of its CAR-T platform by expanding into solid tumors and autoimmune diseases. Contacts Curocell (RIMQARTO) Yura Lee ura.lee@curocellbtx.com

ImmunotherapyFast TrackCell TherapyPhase 2Drug Approval

01 Nov 2023

·www.prnewswire.com

Curocell Completes Korea's First Phase 2 Clinical Trial for Next-Generation CAR-T

Anbal-cel argeting DLBCL completes phase 2 trial Anticipation growing over Korea's first CAR-T therapy ahead of regulatory review Commercial manufacturing scheduled in 2025 at Korea's only CAR-T GMP facility DAEJEON, South Korea, Nov. 1, 2023 /PRNewswire/ -- Curocell, South Korea based CAR-T specialized company (CEO: Gunsoo Kim), has completed Phase 2 clinical trial for its next-generation CD19 CAR-T therapy "Anbal-cel" that targets relapsed or refractory DLBCL (Diffuse Large B-cell Lymphoma). This announcement is a significant milestone and is paving the way towards the launch and approval of Korea's first CAR-T therapy. It has also provied typo new hope for the treatment of patients with DLBCL, an aggressive form of cancer that is growing in prevalence within Korea. The Phase 2 clinical trial evaluated the safety, efficacy and tolerability of "Anbal-cel" in patients with relapsed or refractory DLBCL. It was conducted over a period of 20 months starting in February 2022, enrolling a total of 80 patients from six hospitals across Korea, including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, National Cancer Center, Chonnma typo National University Hospital, and Pusan National University Hospital. "Anbal-cel" is a next-generation CAR-T therapy based on Curocell's OVIS™ technology that significantly inhibits the expression of PD-1 and TIGIT, two types of immune checkpoint receptors, which are known to inhibit anti-tumor function/activity of CAR-T cells. This technology has substantially improved the therapeutic performance of CAR-T therapy in patients with relapsed or refractory DLBCL with a poor prognosis. Curocell made international headlines during the company's oral presentation of its Phase 2 clinical trial interim results at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland back in June. The interim results analyzed the efficacy and safety of its CAR-T treatment in 41 patients participating in the Phase 2 trial. The complete response rate (CRR: Rate at which the cancer enters into full remission) observed in the interim results was 71%, showing an improved therpeutic effect compared to the 40 to 50% CRR range for three FDA-approved CAR-T therapies currently on the market. Curocell plans to officially announce the final results of its Phase 2 clinical trial for "Anbal-cel" in the first half of next year and submit an BLA application to Korea's Ministry of Food and Drug Safety for approval next September. Starting from the expected year of approval in 2025, the company is planning to launch the supply of commercial products from Korea's only large-scale GMP facility dedicated to the production of CAR-T boasting state-of-the-art equipment. CEO of Curocell, Gunsoo Kim said that, "I am extremely proud that we were able to complete Korea's first clinical Trial or study for CAR-T therapy in such a short period of time, which I believe is one of the most remarkable achievement in the history of drug development in Korea." He added, "We will make every effort to obtain approval for Anbal-cel in 2025 and ensure sustained growth for the company through future expansion in our overseas business." The clinical trial for "Anbal-cel" was officially selected by the Korea Drug Development Fund (KDDF) in 2021 as the target of a government grant. It was conducted with the support of the National New Drug Development Project Team, funded by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare. (Project Number: HN21C0653) Corporate Overview "Fight Against Hopelessness: Curocell is spearheading the development of innovative cancer immunotherapies" Curocell is Korea's first company specialized in CAR-T treatment, developing CAR-T cell therapies that have become one of the world's most promising new drugs to emerge in recent years. Curocell's technology aims to overcome the limitations of existing cancer immunotherapies to treat a wide variety of different cancer types. Curocell is working with top experts in various fields such as CAR-T technology development, biopharmaceutical development, production and GMP, while also collaboaring with major Korean hospitals for the systematic development of new CAR-T cell therapies. Curocell is Korea's first company to obtain regulatory approval to conduct CAR-T clinical trials, and is widely recognized as the country's leading company in the field of CAR-T cell therapy, possessing a large-scale commercial GMP facility with state-of-the-art equipment to manufacture its products. "CAR-T cell therapy, a next generation cancer immunotherapy" CAR-T (Chimeric Antigen Receptor-T) cell therapy is a next generation cancer immunotherapy that involves genetically modifying a patient's immune T cells in vitro to express antigens that specifically target cancer cells, then reintroducing them into the patient to destroy the cancer. Through the process of separating the patient's immune cells, modifying their genes, and cultivating them en masse, it is possible to achieve complete remission in a terminal leukemia patient with just a single administration where no other treatment options are available. SOURCE Crucocell Inc.

Phase 2ImmunotherapyClinical ResultCell TherapyIND

13 Jun 2022

·www.prnewswire.com

Curocell announced impressive CR rate in Phase 1 study with anbal-cel, the next generation CD19 CAR-T integrated OVIS™ platform

- 82% ORR (9 of 11 patients) and 82% (9 of 11 patients) CR rate documented after anbal-cel treatment to the patients in relapsed/refractory large B-cell lymphoma - 2 out of 3 patients dosed with 2x105 cells/kg of anbal-cel lasting the complete response for more than 12 months - Well tolerated up to 2X106 cells/kg dose level without DLT and not reached to MTD in Phase 1 dose escalation study DAEJEON, South Korea, June 13, 2022 /PRNewswire/ -- Curocell, Inc., a leading CAR-T company based in South Korea, announced the phase 1 dose-escalation study results documenting an 82% complete remission (CR) rate after a single dose of anbalcabtagene autoleucel (anbal-cel) to relapsed/refractory large B-cell lymphoma patients. Three (3) among 4 patients dosed at 2x105 cells/kg of anbal-cel documented complete remission, and 2 responding patients are maintaining the complete remission for more than a year. Strikingly, all patients dosed with 2x106 cells/kg reported complete remission after a single dose of anbal-cel. The complete phase 1 study results were presented at EHA at EHA (European Hematology Association) congress, Vienna, Austria, Jun 09-17, 2022. The anbal-cel is the CD19 CAR-T integrated with the OVISTM (Overcome Immune Suppression) platform. OVISTM technology consists of a dual knockdown system for two crucial immune checkpoint receptors, PD-1 and TIGIT, in CAR-T cells. "Although CD19 directed CAR-T therapy changed the treatment paradigm for Large B-cell lymphoma, which is one of the most aggressive hematologic malignant cancer, more than 50% of LBCL patients didn't experience the clinical benefit of CD19 CAR-T treatment, and there are still huge unmet medical needs. Anbal-cel's phase 1 study result demonstrates the OVISTM platform's potential to maximize CAR-T's functionality to eradicate tumors. We are very excited about this promising clinical result even though the patient number treated with anbal-cel is limited with a total of 11 and looking forward to the ongoing phase 2 clinical trial to confirm the efficacy and safety of anbal-cel. Furthermore, we believe these data represent the excellence of our next-generation CAR-T technology." said Gunsoo Kim, Curocell's chief executive officer. This phase 1 study was to evaluate the safety and preliminary efficacy in patients with r/rLBCL. Patient was infused as a single intravenous dose with 2x105 cells/kg (Dose Level 1), 7x105 cells/kg (DL2) or 2x106 cells/kg (DL3). Lymphodepletion with cyclophosphamide (500mg/m2) and fludarabine (30mg/m2) was performed for 3 days prior to anbal-cel infusion. Eleven (11) patients with r/r DLBCL were infused with anbal-cel. All patients received two or more prior lines of therapy, and 36% (4/11) received ≥4 prior lines of treatment before the study. No patient experienced DLT during the study. Of the 11 patients, 5 (46%) patients experienced CRS; 3 (27%) were grade 1 or 2 and 2 (18%) experienced grade 3 CRS. The median time to onset of CRS was 7 days (range, 1-16) with a median duration of 5 days (range, 1-19). One patient dosed with 2x106 cells/kg experienced grade 2 ICANS; the time to onset of ICANS was 7 days and lasted for 13 days. This patient had prior CNS involvement history before the study. The frequently reported grade 3/4 treatment related AEs were anemia (2/11, 18%), neutropenia (2/11, 18%), thrombocytopenia (2/11, 18%), CRS (2/11, 18%). Dose-dependent CRC01 expansion was observed; median Tmax was 15.4, 15.8 and 14.5 days at DL1, DL2 & DL3 each; Cmax, AUC0-28 day was dose proportionally increased. Based on promising safety and efficacy data from Phase 1 study, Phase 2 trial has been commenced, and patient enrollment is ongoing. Details of the oral presentation at EHA are as follows: Submission ID: EHA-3438 Title: PHASE 1/2 STUDY OF ANBAL-CEL, NOVEL ANTI-CD19 CAR-T THERAPY WITH DUAL SILENCING OF PD-1 AND TIGIT IN RELAPSED OR REFRACTORY LARGE B CELL LYMPHOMA Session Title: Aggressive Lymphoma - CART Session date and time: Saturday, June 11 11:30 - 12:45 Session room: Hall A7 Final Abstract Code: S214 About anbalcabtagene autoleucel (anbal-cel) Anbal-cel, recognized CD19 and is based on OVISTM, a first-in-class CAR-T platform. OVISTM technology downregulates PD1 and TIGIT expression in CAR-T cells. Through overcoming the immune suppression by PD-L1 and TIGIT ligands, OVISTM CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. The Phase 2 clinical trial of anbal-cel has initiated in South Korea in the first half of 2022. About Curocell, Inc. Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVISTM technology intending to improve the clinical efficacy of CAR-T therapies. For more information, visit . SOURCE Curocell, Inc.

First in Class

100 Deals associated with Anbalcabtagene autoleucel

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diffuse large B-cell lymphoma recurrent	South Korea	Curocell, Inc.	30 Apr 2026
Primary mediastinal large B-cell lymphoma recurrent	South Korea	Curocell, Inc.	30 Apr 2026
Diffuse Large B-Cell Lymphoma	South Korea	Curocell, Inc.	29 Apr 2026
Mediastinal large B-cell lymphoma	South Korea	Curocell, Inc.	29 Apr 2026

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Lupus Nephritis	Phase 2	-	Curocell, Inc.	01 Feb 2026
Recurrent Central Nervous System Lymphoma	Phase 2	South Korea	Asan Medical Center	12 Nov 2025
Refractory Central Nervous System Lymphoma	Phase 2	South Korea	Asan Medical Center	12 Nov 2025
Follicular Lymphoma	Phase 2	South Korea	Curocell, Inc.	02 Mar 2021
High grade B-cell lymphoma	Phase 2	South Korea	Curocell, Inc.	02 Mar 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2023	Phase 2	Carney Complex CD19 \| PD-L1 \| CD112/CD155 ... View more	-	Anbal-cel	kmotvsfeel(swsjqyzkdr) = lztnkmdfpe ifqpvwwsoj (fozeibgxiw )	-	23 Oct 2023
ICML2023	Not Applicable	Large B-cell lymphoma	-	Anbal-cel	ulbezrseuc(omxhxsaytk) = Responder group (CR) reported higher incidence and severity of CRS compared to non-responder group (Non-CR), but it was insignificant. rekxqrnwkf (bscfkemwfz ) View more	-	09 Jun 2023
NCT04836507 (ESMO_ASIA2022) Manual	Phase 1/2	Diffuse Large B-Cell Lymphoma	11	CRC-01	nplbstfaji(alogngqoov) = Anemia 22%, neutropenia 82%, thrombocytopenia 55% murtkoqboo (uyazhitgle )	Positive	04 Dec 2022
NCT04836507 (ASCO2022) Manual	Phase 1/2	B-Cell Lymphoma	9	CRC-01	qigwkstfha(mlafxmckno) = iaeobsnboe kooruppokf (zcshjsdmiy ) View more	Positive	02 Jun 2022

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Anbalcabtagene autoleucel

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation