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CARsgen’s CT041 Awarded Breakthrough Therapy Designation for Gastric Cancer
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CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that its chimeric antigen receptor (CAR) T-cell therapy, Satricabtagene autoleucel (CT041), has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is Claudin18.2-positive advanced gastric / gastroesophageal junction cancer (G…
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CARsgen Therapeutics Administers KJ-C2219 in SLE Patient in IIT
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that it has administered its KJ-C2219 at the starting dose specified in the clinical protocol in the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated trial (IIT). Therapy DetailsKJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, was developed via CARsgen’s THANK-u…
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CARsgen Therapeutics and Zhuhai SB Xinchuang Invest in UCARsgen for Allogeneic CAR-T Therapies
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has entered into an agreement with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) to jointly invest in its subsidiary UCARsgen Biotech Limited. UCARsgen focuses on developing allogeneic CAR-T cell therapies for hematologic malignancies. Deal Highlights
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CARsgen’s Allogeneic BCMA CAR-T Therapy Achieves sCR in First Patient
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the first patient treated with its allogeneic BCMA chimeric antigen receptor (CAR)-T therapy, developed on the THANK-u Plus platform, achieved a stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment. Patient Background and TreatmentThe patient, diagnosed…
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CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2320 in AML
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the first subject dosing in an investigator-initiated trial (ITT) for its KJ-C2320, a universal chimeric antigen receptor (CAR)-T cell therapy targeting recurrent/refractory acute myeloid leukemia (R/R AML). This milestone marks a significant step forward in the development of innovative treatments for…
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CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2219 in China
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of an investigator-initiated-trial (ITT) for its chimeric antigen receptor (CAR)-T therapy candidate product, KJ-C2219, in China. The trial is aimed at treating recurrent/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). KJ-C2219: A Universal CAR-T Therapy Targeting CD19 and CD20KJ-C2219 is a…
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CARsgen Therapeutics’ Satricabtagene Autoleucel Shows Positive Results in Phase II Study
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced positive results from its pivotal Phase II CT041-ST-01 study for satricabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy. The study, which is randomized, controlled, and multi-center, aims to evaluate the efficacy and safety of the therapy in patients with CLDN18.2-expressing…
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CARSgen Therapeutics Presents Latest CAR-T Data at ASH Annual Meeting
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CARSgen Therapeutics Holdings Ltd (HKG: 2171), a China-based specialist in chimeric antigen receptor (CAR)-T cell therapies, has announced the presentation of the latest data for its CAR-T therapies, CT053 (zevorcabtagene autoleucel; zevor-cel), CT071, and CT0590, at the 66th American Society of Hematology (ASH) annual meeting. CT053 Phase II Study Subgroup…
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CARsgen Therapeutics’ Suspended CAR-T Therapies Get FDA Green Light to Resume
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The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for three chimeric antigen receptor (CAR)-T therapies developed by CARsgen Therapeutics Holdings Ltd (HKG: 2171), according to the company’s statement to the Hong Kong Stock Exchange. The therapies include CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy…
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CARsgen Completes Patient Enrollment for Phase II Trial of CT041 in Advanced Gastric Cancer
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a leading China-based developer of chimeric antigen receptor (CAR)-T cell therapies, has announced the completion of patient enrollment in a confirmatory Phase II clinical trial for its investigational CAR-T therapy, CT041. The study aims to evaluate CT041 as a potential treatment for advanced gastric…
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CARsgen Therapeutics’ Saikaize and CT071 Show Strong Results in EHA Clinical Trials
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CARsgen Therapeutics, a biopharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 2171), has announced promising results from two pivotal clinical trials at the 29th European Hematology Association Annual Meeting. The data presented highlights the potential of two CAR-T therapies: Saikaize (zevorcabtagene autoleucel), an autologous BCMA-targeted therapy for multiple…
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CARsgen Therapeutics Submits CAPA Report to US FDA Following Clinical Hold
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced the filing of its Corrective And Preventive Actions (CAPAs) report with the US Food and Drug Administration (FDA). This follows a previous request by the FDA in December last year…
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CARsgen Launches BCMA-Targeted CAR-T Therapy in China with High Price Point
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China-based CAR-T cell therapy specialist CARsgen Therapeutics Holdings Ltd. (HKG: 2171) has launched its BCMA-targeted CAR-T cell therapy, CT053 (zevorcabtagene autoleucel; zevor-cel), with a price tag of RMB 1.15 million (USD 160,000), as reported by The Paper, a local media outlet. The company anticipates that the drug’s annual end sales…
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CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
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CARsgen Therapeutics’ CT041 Shows Promising Results in Advanced Solid Tumors at ASCO GI 2024
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China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the presentation of interim results from the Phase Ib ELIMYN18.2 study’s dosage escalation phase for its pipeline asset, CT041. The data will be showcased at the esteemed 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2024). The study is…
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CARsgen Therapeutics Gets NMPA Approval for CAR-T Therapy CT011 in Hepatocellular Carcinoma
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its chimeric antigen receptor (CAR)-T therapy, CT011. The study will focus on patients with GPC3 positive stage IIIa hepatocellular carcinoma (HCC) who are…
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CARsgen Therapeutics Halts Clinical Studies for Three CAR-T Therapies in the US Following FDA Request
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the US Food and Drug Administration (FDA) has requested its US subsidiary, CARsgen Therapeutics Corporation, to place clinical studies for CT053, CT041, and CT071 on hold. These chimeric antigen receptor (CAR)-T therapies are on hold pending the FDA’s conclusion after…
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CARsgen Therapeutics Secures U.S. FDA Approval for CT071 Clinical Trials in Multiple Myeloma
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), based in China, has announced that it has received clinical trial approval from the U.S. FDA for its chimeric antigen receptor (CAR)-T cell product, CT071, aimed at treating recurrent/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (PCL). CT071 is developed using the…
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CARsgen Therapeutics Partners with Moderna to Combine CAR-T Therapy with mRNA Cancer Vaccine
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced a collaboration agreement with US mRNA giant Moderna Inc. (NASDAQ: MRNA). The partnership aims to investigate the use of CARsgen’s investigational Claudin18.2 (CLDN18.2)-targeted chimeric antigen receptor (CAR) T-cell product candidate, CT041, in combination with Moderna’s investigational CLDN18.2 mRNA cancer vaccine. Combining…
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CARSgen Therapeutics Initiates Phase II Study for CT041 in Advanced Gastric Cancer
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China-based chimeric antigen receptor (CAR)-T cell specialist CARSgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of patient enrollment for a Phase II clinical study of its CT041 in advanced gastric cancer/esophageal gastric junction adenocarcinoma (GC/GEJ) with positive CLDN18.2 expression that has previously failed at least second-line treatment. CT041:…
