Shanghai Cell Therapy Group's Chemotherapy-Free, Tri-Target CAR-T (BZE2204) Achieves 100% Response Rate in Relapsed/Refractory Lymphoma Patients

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Recently, Shanghai Cell Therapy Group announced: its self-developed world's first triple-target hematological tumor CAR-T（BZE2204，CD19/CD22/BCMA CAR-T）, adopting an ultra-short production process (6 hours), has achieved milestone results in the clinical scientific research of product BZE2204 in collaboration with Mengchao Cancer Hospital affiliated to Shanghai University.

It is worth mentioning that this therapy, which adopts a 6-hour ultra-fast preparation process, demonstrates significantly superior in vivo proliferation ability without the need for lymphodepletion chemotherapy compared to the in vivo proliferation ability of commercially available CAR-T therapies under lymphodepletion conditions, andDriving 3 cases of refractory diffuse large B-cell lymphoma to achieve 100% complete remission provides the first clinical evidence for avoiding the toxic risk of chemotherapy while maintaining high efficacy.

ZE2204 is an innovative therapy jointly developed by Shanghai Cell Therapy Group, Mengchao Cancer Hospital affiliated with Shanghai University, and the U.S. subsidiary Chantibody. It is based on the JL-Light-CAR-T™ technology platform and represents an ultra-fast, non-viral vector, triple-target (CD19, CD22, BCMA) CAR-T cell therapy that does not require ex vivo culture. The therapy leverages two versions of the JL-Lightning-CAR-T rapid production process, V-30h and V-6h, which eliminate the need for culturing after transfection, thereby enhancing CAR-T stem cell properties and in vivo expansion. The entire process from apheresis to formulation can be completed in as little as 6 hours, maximizing the preservation of T-cell stemness and expansion capacity. It has demonstrated excellent anti-tumor effects in preclinical animal experiments and IIT clinical trials, representing the integration of light CAR-T preparation technology and multi-target CAR design innovation.

In the study, among the 8 enrolled patients with relapsed and refractory non-Hodgkin lymphoma (including 3 patients treated with a chemotherapy-free lymphodepletion regimen using CAR-T), 7 achieved complete remission and 1 achieved partial remission. The overall objective response rate (ORR) reached 100%, and the complete remission rate (CRR) reached 87.5%. Analysis revealed that under the chemotherapy-based lymphodepletion regimen, the average in vivo proliferation capacity of CAR-T exceeded that of marketed CAR-T products by more than 100 times, without any ≥Grade 3 cytokine release syndrome or neurotoxicity. This finding has driven further exploration of the clinical value of chemotherapy-free lymphodepletion regimens. In an investigator-initiated trial (IIT) involving 3 patients with refractory diffuse large B-cell lymphoma treated with the chemotherapy-free lymphodepletion regimen JL-Flash CAR-T, both the objective response rate (ORR) and complete remission rate (CRR) reached 100%. No ≥Grade 3 hematological toxicity, infection, cytokine release syndrome, or neurotoxicity was observed. Patients maintained sustained deep remission post-infusion, demonstrating significant safety advantages. This marks that JL-Flash CAR-T achieves high efficacy while eliminating the toxic risks associated with chemotherapy-based lymphodepletion.