[Translation] An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of adjuvant chemotherapy followed by CT041 autologous CAR-T cell injection in patients with pancreatic cancer

主要目的：评价CT041用于胰腺癌术后辅助治疗的有效性；次要目的：评价CT041治疗的安全性和耐受性，评价CT041用于胰腺癌术后辅助治疗受试者的其他有效性指标，评价受试者输注CT041的细胞代谢动力学，评价受试者输注CT041的免疫原性探索性目的：探索影响CT041有效性的因素，探索CT041对受试者生活质量的影响

[Translation]

Primary purpose: To evaluate the effectiveness of CT041 in adjuvant therapy for pancreatic cancer after surgery; Secondary purpose: To evaluate the safety and tolerability of CT041 treatment, to evaluate other effectiveness indicators of CT041 in adjuvant therapy for pancreatic cancer after surgery, to evaluate the cellular metabolic kinetics of CT041 infused into subjects, and to evaluate the immunogenicity of CT041 infused into subjects Exploratory purpose: To explore the factors affecting the effectiveness of CT041 and the effect of CT041 on the quality of life of subjects

Start Date03 Aug 2023

Sponsor / Collaborator

Carsgen Pharmaceuticals Co., Ltd.Startup

NCT05911217 / RecruitingPhase 1

An Open-label, Single-arm, Multicenter, Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of CT041 Autologous CAR T Cell Injection After Adjuvant Chemotherapy in Subjects With Pancreatic Cancer

An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.

Start Date11 Jul 2023

Sponsor / Collaborator

CARsgen Therapeutics Co. Ltd.

[+1]

NCT04404595 / Active, not recruitingPhase 1/2

Open-label, Multicenter, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Subjects With Advanced Gastric, Pancreatic, or Other Specified Digestive System Cancers

A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers

Start Date23 Oct 2020

Sponsor / Collaborator

CARsgen Therapeutics Co. Ltd.

100 Clinical Results associated with Satricabtagene autoleucel

100 Translational Medicine associated with Satricabtagene autoleucel

100 Patents (Medical) associated with Satricabtagene autoleucel

Literatures (Medical) associated with Satricabtagene autoleucel

31 Dec 2024·Journal of Medical Economics

Cost-effectiveness of axicabtagene ciloleucel versus tisagenlecleucel for the treatment of 3L + relapsed/refractory large B-cell lymphoma in the United States: incorporating longer survival results

Article

Author: Locke, Frederick L ; Patel, Anik R ; Davies, Neil ; Oluwole, Olalekan O ; Bradford, Rory ; Jones, Calum ; Ray, Markqayne D

AIMSTo provide an update on the cost-effectiveness of the chimeric antigen receptor (CAR) T-cell therapies axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) for the treatment of relapsed/refractory (r/r) large B-cell lymphoma (LBCL) among patients who have previously received ≥2 lines of systemic therapy using more mature clinical trial data cuts (60 months for axi-cel overall survival [OS] and 45 months for tisa-cel OS and progression-free survival [PFS]).METHODSA partitioned survival model consisting of three health states (pre-progression, post-progression and death) was used to estimate quality-adjusted life years (QALYs) and costs associated with axi-cel and tisa-cel over a lifetime horizon. PFS and OS inputs for axi-cel and tisa-cel were based on a previously published matching-adjusted indirect treatment comparison (MAIC). Long-term OS and PFS were extrapolated using parametric survival mixture cure models (PS-MCMs). Costs of CAR-T cell therapy drug acquisition and administration, conditioning chemotherapy, apheresis, CAR T-specific monitoring, stem cell transplant, hospitalization, adverse events, routine care, and terminal care were sourced from US cost databases. Health state utilities were derived from previous publications. Model inputs were varied using a range of sensitivity and scenario analyses.RESULTSCompared with tisa-cel, axi-cel resulted in 2.51 additional QALYs and $50,185 additional costs (an incremental cost-effectiveness ratio [ICER] of $19,994 per QALY gained). In probabilistic sensitivity analysis (PSA), the ICER for axi-cel versus tisa-cel was ≤$50,000/QALY in 99.4% of simulations and ≤$33,500 in 99% of simulations. Axi-cel remained cost-effective versus tisa-cel (assuming a willingness-to-pay threshold of $150,000 per QALY) across a range of scenarios.CONCLUSIONSWith longer-term survival data, axi-cel continues to represent a cost-effective option versus tisa-cel for treatment of r/r LBCL among patients who have previously received ≥2 lines of systemic therapy, from a US payer perspective.

31 Dec 2024·Journal of Medical Economics

Cost-effectiveness analysis of mosunetuzumab for treatment of relapsed or refractory follicular lymphoma after two or more lines of systemic therapy in the United States

Article

Author: Sanchez Alvarez, Javier ; Parisé, Hélène ; Zuk, Eric ; Matasar, Matthew ; Kim, Eunice ; Shapouri, Sheila ; Di Maio, Danilo ; Lin, Shih-Wen

AIMSMosunetuzumab has received accelerated approval by the US Food and Drug Administration for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. We evaluated the cost-effectiveness of mosunetuzumab for the treatment of R/R FL from a US private payer perspective.MATERIALS AND METHODSA partitioned survival model simulated lifetime costs and outcomes of mosunetuzumab against seven comparators: axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), tazemetostat (taz, EZH2 wild-type only), rituximab plus lenalidomide (R-Len) or bendamustine (R-Benda), obinutuzumab plus bendamustine (O-Benda), and a retrospective real-world cohort (RW) based on current patterns of care derived from US electronic health records (Flatiron Health). Efficacy data for mosunetuzumab were from the pivotal Phase II GO29781 trial (NCT02500407). Relative treatment efficacy was estimated from indirect treatment comparisons (ITCs). Costs included were related to treatment, adverse events, routine care, and terminal care. Except for drug costs (March 2023), all costs were inflated to 2022 US dollars. Costs and quality-adjusted life-years (QALYs) were used to calculate incremental cost-effectiveness ratios (ICERs). Net monetary benefit (NMB) was calculated using a willingness-to-pay (WTP) threshold of $150,000/QALY.RESULTSMosunetuzumab dominated taz, tisa-cel, and axi-cel with greater QALYs and lower costs. Mosunetuzumab was projected to be cost-effective against R-Benda, O-Benda, and RW with ICERs of $78,607, $42,731, and $21,434, respectively. Mosunetuzumab incurred lower costs but lower QALYs vs. R-Len. NMBs showed that mosunetuzumab was cost-effective against comparators except R-Len.LIMITATIONSWithout head-to-head comparative data, the model had to rely on ITCs, some of which were affected by residual bias. Model inputs were obtained from multiple sources. Extensive sensitivity analyses assessed the importance of these uncertainties.CONCLUSIONMosunetuzumab is estimated to be cost-effective compared with approved regimens except R-Len for the treatment of adults with R/R FL.

01 Nov 2024·Transplantation and Cellular Therapy

Real-World Analysis of Barriers to Timely Administration of Chimeric Antigen Receptor T Cell (CAR T) Therapy in Diffuse Large B-cell Lymphoma

Article

Author: Elder, Jennifer ; Boseman, Victoria ; Hu, Bei ; Copelan, Edward A ; Jacobs, Ryan W ; Jennings, Rebecca D ; Vaidya, Rakhee ; Howard, Dianna S ; Ghosh, Nilanjan ; Avalos, Belinda ; Moyo, Tamara K ; Park, Steven ; Shroff, Vishal ; Wallander, Michelle ; Pang, Yifan ; Ahmed, Ferdous ; Beam, Travis ; Mesa, Ruben ; Yountz, Melissa ; Wallander, Michelle L ; Ehsan, Hamid

The implementation of chimeric antigen receptor T (CAR T) therapy in the real-world setting is hindered by logistical and financial barriers, impacting timely access to this life-saving treatment. Clinical trials have reported the time from leukapheresis to CAR T cell infusion (vein-to-vein time) but not the time from CAR T referral to infusion (decision-to-vein time). Herein, we report the barriers to CAR T therapy in a real-world setting. We evaluated the factors influencing the decision-to-vein time and explored the association with clinical outcomes in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who received CAR T therapy. We conducted a retrospective study of adult patients with relapsed/refractory DLBCL who underwent consultation for CAR T cell therapy at Levine Cancer Institute and Wake Forest Comprehensive Cancer Center and collected information regarding demographic data, referral type, insurance type, CAR T product, and survival outcomes. The effects of variables on decision-to-vein time were analyzed by Fisher's exact test for categorial variables and Wilcoxon rank-sum test for continuous variables. Survival analyses were performed using Kaplan-Meier and Cox Proportional Hazard models. The study included 142 patients who were referred for CAR T of which 99 patients received CAR T. Median decision-to-vein time was 62 days compared to median vein-to-vein time of 32 days. Patients with private insurance took longer to obtain financial clearance compared to patients with government insurance (median 25 versus 9 days, P < .001). Of those with private insurance (n = 63), 35% needed a single-case agreement (SCA) which led to significant delay in receiving financial clearance (median 50.5 versus 19 days, P < .001) and increased decision-to-vein time (median 75 versus 55 days, P < .001) compared to those who did not need SCA. Decision-to-vein time was significantly different among various products, clinical trial being the shortest (median 47 days, n = 9) and non-conforming products being the longest (median 94.5 days, n = 6) (P< .001). Axi-cel had the shortest median decision-to-vein time at 61 days compared to 81 days with tisa-cel and 85 days with liso-cel. Although delays in receiving CAR T therapy did not impact survival, the median overall survival for patients who were referred for CAR T therapy but did not receive it, was significantly lower than those who received CAR T cell therapy (9.0 versus 21.0 months, P < .001). Decision-to-vein time is a major cause of delay in receiving CAR T therapy. SCAs lead to significant increase in decision-to-vein time leading to delays in CAR T therapy in a real-world setting. Patients who were referred for CAR T but are not able to receive it, have inferior survival compared to CAR T recipients. Our findings underscore the significance of addressing administrative hurdles, such as SCAs and insurance approvals, for timely access to CAR T therapy for patients with DLBCL.

News (Medical) associated with Satricabtagene autoleucel

01 Nov 2024

·endpts.com

FDA removes hold on three CARsgen CAR-T trials; Ono passes on itolizumab

Plus, news about Kymera Therapeutics, Nanoscope, Eupraxia, Alpha Cognition and EyePoint: FDA lifts hold of CARsgen’s CAR-T therapies: The FDA on Thursday lifted a clinical hold on three of CARsgen Therapeutics’ CAR-T therapies. The trials were halted in December due to issues found at the company’s manufacturing facilities in Durham, NC. The drugs — CT053, CT041 and CT071 — are being investigated against BCMA, Claudin18.2 and GPRC5D, respectively. — Anna Brown Ono lets option for itolizumab expire: The company signed an agreement with Equillium in 2022 to potentially purchase an IgG1 monoclonal antibody in graft versus host disease. But Ono decided not to acquire the drug, with Equillium’s stock $EQ closing 37% lower on Thursday. Equillium also reorganized its pipeline and paused enrollment of a Phase 3 study of itolizumab, according to an SEC filing . — Max Gelman Kymera Therapeutics ends oncology work: The biotech will instead focus on its immunology pipeline , which includes STAT6, IRAK4 and TYK2 degrader programs. Two cancer drugs will not proceed past Phase 1 development. Kymera said it is “evaluating partnership opportunities” for them. — Max Gelman Nanoscope’s two-year data for eye disease gene therapy: The program, MCO-010, is being developed for permanent and severe vision loss from advanced retinitis pigmentosa. The high-dose group had a statistically significant improvement in patients being able to read an eye chart after 52 and 76 weeks. There were no serious side effects, and the most commonly reported ones were hypertension in different parts of the eye. — Max Gelman Eupraxia discloses $32M private placement: The Canadian company plans to use the funding to support research into its experimental treatment for eosinophilic esophagitis. — Jaimy Lee Alpha Cognition’s $25M offering: The Vancouver biotech, which makes neurodegenerative disease treatments, also plans to uplist to the Nasdaq . — Kyle LaHucik EyePoint ended up raising $161 million in its upsized public offering. — Jaimy Lee

AcquisitionGene TherapyPhase 3Cell TherapyImmunotherapy

01 Nov 2024

·www.prnewswire.com

CARsgen® U.S. Clinical Holds Lifted by FDA

SHANGHAI, Oct. 31, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the U.S. Food and Drug Administration ("FDA") lifted the clinical holds on clinical trials of zevorcabtagene autoleucel (zevor-cel, CT053, an autologous CAR-T product against BCMA), satricabtagene autoleucel (satri-cel, CT041, an autologous CAR-T product against Claudin18.2), and CT071 (an autologous CAR-T product against GPRC5D) in the United States. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S., focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Internally, CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. For more information, please visit SOURCE CARsgen Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cell TherapyImmunotherapyClinical Study

01 Nov 2024

·www.pharmamanufacturing.com

FDA lifts clinical holds on CARsgen’s CAR T-cell therapy trials

The FDA has lifted clinical holds on three CAR T-cell therapy trials conducted by CARsgen Therapeutics, the company announced today. The affected trials include CT053, a CAR T-cell therapy targeting BCMA for refractory or relapsed multiple myeloma; CT041, which targets Claudin18.2 for treating solid tumors like gastric/gastroesophageal junction cancer and pancreatic cancer; and CT071, aimed at GPRC5D for relapsed or refractory multiple myeloma and primary plasma cell leukemia. The holds were placed due to concerns related to chemistry, manufacturing, and controls (CMC) following an inspection of the company’s manufacturing facility in Durham, North Carolina last December. Now, the trials are set to resume in the United States.

Cell TherapyImmunotherapyClinical Study

100 Deals associated with Satricabtagene autoleucel

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	Phase 2	CN	CARsgen Therapeutics Co. Ltd.	04 Mar 2022
Advanced Gastric Adenocarcinoma	Phase 2	CN	Carsgen Pharmaceuticals Co., Ltd.Startup	23 Oct 2020
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 2	CN	Carsgen Pharmaceuticals Co., Ltd.Startup	23 Oct 2020
Pancreatic Cancer	Phase 2	CN	Carsgen Pharmaceuticals Co., Ltd.Startup	23 Oct 2020
Pancreatic Cancer	Phase 2	CA	CARsgen Therapeutics Co. Ltd.	23 Oct 2020
Pancreatic Cancer	Phase 2	US	CARsgen Therapeutics Co. Ltd.	23 Oct 2020
Stomach Cancer	Phase 2	US	CARsgen Therapeutics Co. Ltd.	23 Oct 2020
Stomach Cancer	Phase 2	CA	CARsgen Therapeutics Co. Ltd.	23 Oct 2020
CLDN18.2 positive Pancreatic Cancer	Phase 1	CN	Carsgen Pharmaceuticals Co., Ltd.Startup	03 Aug 2023
stomach adenocarcinoma	Preclinical	CN	CARsgen Therapeutics Co. Ltd.	23 Oct 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03874897 (CT041-CG4006, Pubmed) Manual	Phase 1	Gastrointestinal Neoplasms	98	Satricabtagene autoleucel (satri-cel)/CT041 (dose-escalation stage)	(cxbxvgoixl) = None ocqereujnh (vrobptgfdr ) View more	Positive	03 Jun 2024
				Satri-cel monotherapy (dose-expansion stage)
NCT03874897 (CT041-CG4006, ASCO2024) Manual	Phase 1	Gastrointestinal Neoplasms First line	98	CT041	(xcittgwvut) = grade 3 or higher were hematologic toxicity related to lymphodepletion vafmagzrcz (ixdlzwlmmc ) View more	Positive	24 May 2024
				CT041 (gastric cancer)
NCT04581473 \| NCT03874897 (Pubmed)	Phase 1	Secondary malignant neoplasm of pancreas CA19-9	24	CT041	ykgvbmuwxh(amgzvbnasd) = Cytokine release syndrome (CRS) and GI disorders were most reported grade 1 or 2 adverse events ovmhijtvkw (pzldlkuuyz ) View more	Positive	24 May 2024
NCT04404595 (ELIMYN18.2, PRNewswire) Manual	Phase 1/2	Prostatic Cancer \| CLDN18.2 positive Gastrooesophageal junction cancer \| CLDN18.2 positive Stomach Cancer	19	satri-cel (GC/GEJ)	(cngxvmlebb) = nopxawrefa olfangercb (wjroqzvoje ) View more	Positive	19 Jan 2024
				satri-cel (DL3：600×106)	(jzqredgkoq) = xwwpoyzcfb gwhysmgqlv (tksqnxudcw ) View more
NCT04581473 (CT041-ST-01, ASCO2022) Manual	Phase 1/2	Advanced Gastric Adenocarcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma Claudin-18 isoform 2 Expression	14	CT041	(nrmojybhzp) = Most CRS were grade 1 or 2, and only one patient experienced grade 4 CRS and fully recovered khrrbyahkm (hqzcaxisse ) View more	Positive	02 Jun 2022
NCT03874897 (Pubmed \| Nat Med) Manual	Phase 1	Gastrointestinal Neoplasms	37	CT 041	(vufddcdsxa) = hematologic 100% fgogjszgxs (rlfjkrjccr )	Positive	09 May 2022
NCT03874897 (ESMO2021) Manual	Phase 1	Digestive System Neoplasms Third line	37	CT041	(aqmhobjrtv) = nslskmknmm kwjxovxexy (qjlsbvwmgk ) View more	Positive	19 Sep 2021
				CT041 (patients with gastric cancer)	(ckipondqhz) = pauwyitlef wcbxhghtof (gsqzmjjfts, 37.2 - 75.5)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Satricabtagene autoleucel

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation