CARsgen Announces Positive Clinical Data for Allogeneic CAR-T Products CT0596 and CT1190B
Data for CT0596 in Relapsed/Refractory Multiple Myeloma
CT0596 is a BCMA-targeted allogeneic CAR-T cell therapy candidate developed based on CARsgen's THANK-u Plus™ platform and is currently being evaluated in an investigator-initiated trial (IIT) for malignant plasma cell neoplasms. The study has now entered the dose expansion phase with a determined lymphodepletion regimen. Future work will involve dose escalation of the cells to further determine the Recommended Dose (RD).
As of
All 8 infused patients were evaluable for efficacy, with a median follow-up time of 2.56 months (range: 0.9-5.9 months). For lymphodepletion, 6 patients received fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²), while 2 patients received a reduced lymphodepletion dose. Five patients achieved partial response (PR) or above: 3 achieved complete response / stringent complete response (CR/sCR) (all of whom had received the full dose of lymphodepletion), 1 achieved PR, and 1 achieved very good partial response (VGPR). Six patients achieved minimal residual disease (MRD)-negativity at Week 4. No patients got progression disease. Pat 01 has ongoing sCR and MRD negative for nearly 6 months. CAR-T cell expansion was observed in all 8 patients. No dose-limiting toxicities (DLT), treatment discontinuations, or deaths were observed. Four patients experienced Grade 1 cytokine release syndrome (CRS), all of which resolved within 2-10 days.
Previously, in
Data for CT1190B in Relapsed/Refractory Non-Hodgkin's Lymphoma
CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy candidate developed based on CARsgen's THANK-u Plus™ platform and is currently being evaluated in multiple IITs for indications including R/R NHL.
As of
At the lymphodepletion dose of Fludarabine 30mg/m²×3 days + Cyclophosphamide 500mg/m²×3 days, all three FL patients achieved CR. One of these FL patients had failed immunochemotherapy, a PI3K inhibitor, chemotherapy + autologous hematopoietic stem cell transplantation, and CD3/CD20 bispecific antibody therapy; another FL patient had failed immunochemotherapy + autologous hematopoietic stem cell transplantation and CD19 CAR-T therapy. The peak copy number of expansion in these three patients reached 10³-10⁴ copies/µg gDNA.
At the lymphodepletion dose of Fludarabine 30mg/m²×3 days + Cyclophosphamide 1000mg/m²×2 days (the recommended lymphodepletion dose), 8 patients were enrolled, including 2 MCL patients (cell dose 6e8) and 6 DLBCL patients (cell dose 3e8: 1 patient; 4.5e8: 1 patient; 6e8: 4 patients). The details are below:
- 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.
The primary safety signals of CT1190B were CRS, cytopenia, and infections. Other adverse reactions, such as immune effector cell-associated neurologic syndrome (ICANS) and graft versus host disease (GVHD) were not observed.
About CT0596
CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen's proprietary THANK-u Plus™ platform. It is currently being evaluated in investigator-initiated trials for relapsed/refractory multiple myeloma (R/R MM) or plasma cell leukemia (PCL). CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. The company anticipates submitting an Investigational New Drug (IND) application in the second half of 2025.
About CT1190B
CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy developed based on CARsgen's THANK-u Plus™ platform. Ongoing clinical trials include IITs for relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), and for moderate-to-severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc).
About
CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases 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, https://www.carsgen.com. 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.
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