KJ-C2219 / CARsgen - LARVOL DELTA

Multiple allogeneic CAR-T product candidates in development (The Manila Times) - "CT0596 is a BCMA-targeting allogeneic CAR T-cell product...Phase Ib registration trials in China are planned to be initiated in 2026...CT1190B (KJ-C2219) is an allogeneic CAR T-cell product...It is expected to obtain IND approval from the NMPA for B-cell malignancies in 2026. Phase Ib registration study is planned to be initiated in 2026 in China."

New P1 trial • Hematological Malignancies • Multiple Myeloma • Plasma Cell Leukemia

A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD20

CARsgen Signs Strategic Cooperation Agreements to Expand CAR-T Commercial Manufacturing Base in Jinshan, Shanghai (PRNewswire) - "With a total investment amount not exceeding RMB370 million, the Company will establish an advanced commercial manufacturing base for CAR T-cell products in Jinshan District, Shanghai. This move closely aligns with the commercialization progress of the Company's multiple CAR T-cell products, including the marketed product zevorcabtagene autoleucel and the CAR T-cell product satricabtagene autoleucel (R&D code 'CT041') for solid tumor currently in the NDA stage. It also lays the foundation for the future mass production of multiple allogeneic CAR T-cell products (such as CT0596 and CT1190B)."

Licensing / partnership • Hematological Malignancies • Multiple Myeloma • Solid Tumor

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 ) (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Tongji Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Data for CT1190B in Relapsed/Refractory Non-Hodgkin's Lymphoma (PRNewswire) - "Six patients were evaluable for efficacy, achieving an ORR of 83.3%, comprising 4 patients who achieved CR (2 MCL, 2 DLBCL) and 1 patient who achieved PR (DLBCL). Focusing on the 6e8 cell dose, 6 patients were enrolled. Four of them were evaluable for efficacy, and 3 achieved a response, all of which were CR. The remaining 2 DLBCL patients had not reached the timepoint for efficacy assessment. A total of 6 patients received the full lymphodepletion and recommended cell dose, with a median Cmax reaching levels on the order of 10⁵ copies/ug gDNA."

P1 data • PK/PD data • Diffuse Large B Cell Lymphoma • Mantle Cell Lymphoma

KJ-C2219: Targeting CD19/CD20, for the treatment of hematologic malignancies and autoimmune diseases. (Streetinsider.com) - "An IIT for relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) has been initiated at the end of 2024. A separate IIT for systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) has been initiated in the first half of 2025."

Trial status • Non-Hodgkin’s Lymphoma • Systemic Lupus Erythematosus

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 ) (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Tongji Hospital

New P1 trial • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG1101 ) (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Qian Wenbin

New P1 trial • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CARsgen’s Allogeneic CD19/CD20 CAR-T Therapy Administers First Dose in a Patient with Autoimmune Disease (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that KJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, has administered at the starting dose specified in the clinical protocol to the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated trial (IIT)."

Trial status • Systemic Lupus Erythematosus • Systemic Sclerosis

CARsgen Therapeutics Introduced Zhuhai SB Xinchuang to Accelerate Allogeneic CAR-T Cell Products Development in Mainland China (PRNewswire) - "CARsgen Therapeutics...announces reaching agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) ('Zhuhai SB Xinchuang') to jointly invest in UCARsgen Biotech Limited ('UCARsgen')....Under the agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR-T products from CARsgen Therapeutics: the BCMA-targeted allogeneic CAR-T cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR-T cell therapy for the treatment of B-cell malignancies."

Licensing / partnership • Hematological Malignancies • Multiple Myeloma

CARsgen's Allogeneic CD19/CD20 CAR-T Therapy Administers First Dose in an Investigator-Initiated Trial (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that KJ-C2219, an allogeneic CAR T-cell therapy targeting CD19/CD20, has administered the first dose to a patient in an investigator-initiated trial (IIT). KJ-C2219 is developed based on CARsgen's THANK-u Plus platform and is designed for the treatment of hematologic malignancies and autoimmune diseases. An investigator-initiated trial is ongoing in China to evaluate KJ-C2219 for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL)."

Trial status • B Cell Non-Hodgkin Lymphoma

CARsgen Announces the Initiation of an Investigator-Initiated Trial for an Allogeneic CD19/CD20 CAR-T Therapy (PRNewswire) - "CARsgen Therapeutics Holdings...announces the initiation of an investigator-initiated trial (IIT) in China for KJ-C2219, an allogeneic CAR T-cell therapy, targeting CD19/CD20. The trial will evaluate KJ-C2219 for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL)."

Trial status • B Cell Non-Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma