On September 12, 2025, at the 19th National Conference on Hematology of the Chinese Medical Association held in Beijing, Professor Xiaoxi Zhou from the research team led by Director Jia Wei of the Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, delivered a report titled "Development and Clinical Translation of Next-Generation CAR T-Cell Therapy." During the presentation, Professor Zhou highlighted preliminary clinical data from two patients with mantle cell lymphoma (MCL) enrolled in the study and treated with CT1190B, an allogeneic CAR T-cell therapy candidate.
MCL is an aggressive and currently incurable mature B-cell lymphoma characterized by a relapsing pattern, with shortened response and survival durations after disease progression. Patients who experience early relapses following chemoimmunotherapy (CIT) or those with high-risk features have a particularly poor prognosis. Although the introduction of Bruton’s tyrosine kinase inhibitors (BTKi) has revolutionized the treatment landscape for relapsed/refractory (R/R) MCL, patients who develop resistance to BTK inhibitors face a dire prognosis due to a lack of effective treatment options. While autologous CD19 CAR T-cell therapy has demonstrated promising efficacy in these patients, its high cost, complex manufacturing process, and impaired immune function in multidrug-resistant patients limit the preparation and antitumor functionality of autologous CAR T-cells, resulting in limited overall treatment accessibility.
Targeting CD19/CD20, CT1190B is an allogeneic CAR-T therapy developed based on CARsgen’s THANK-u Plus™ platform. According to the report, the investigator-initiated trial (IIT) is ongoing at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, evaluating the safety, efficacy, and cellular pharmacokinetics of CT1190B CAR-T cells in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma (Principal Investigator: Professor Yicheng Zhang). As the first patients enrolled in this study, two individuals with R/R MCL received the same dose of CT1190B following lymphodepletion chemotherapy (fludarabine + cyclophosphamide). Both patients had undergone multiple prior lines of therapy: one had relapsed after chemoimmunotherapy and two BTK inhibitors, while the other had relapsed after chemoimmunotherapy, a BTK inhibitor, and a BCL2 inhibitor. After CT1190B infusion, both patients experienced short-term cytopenia and cytokine release syndrome (CRS), which improved with supportive care. No other adverse events, such as immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GVHD), were observed.
As of the data cutoff, one patient achieved complete response in the tumor assessment at week 4. The other patient met discharge criteria on day 11 after infusion following hematological recovery and continued with outpatient follow-up, not yet reaching the time point for efficacy evaluation. Both patients exhibited robust CAR-T expansion, with peak levels reaching 105 copies/µg gDNA. The current data support further exploration of CT1190B for the treatment of relapsed/refractory mantle cell lymphoma.
*The screenshots are from the presentation at the 19th National Conference on Hematology of the Chinese Medical Association and are for reference only.
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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.
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