Cellular Biomedicine Group Inc. announced that the Food and Drug Administration (FDA) granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting both CD19 and CD20 antigens, both Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation for the treatment of patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL). Early clinical results of C-CAR039 from an investigator-initiated trial (IIT) conducted across multiple sites in China demonstrate exciting efficacy and favorable safety data of C-CAR039 in r/r B-cell NHL. As of April 20, 2021, a total of 34 patients received C-CAR039 cell therapies, with 28 patients evaluable for safety analyses and 27 patients evaluable for efficacy analyses.

Patients' median age was 55.5 years, and 75% had cancer of Ann Arbor stage III/IV. Patients had a median of three prior lines of therapy. Bridging therapy had been given to 17.9% of patients.

The best overall response rate (ORR) was reported to be 92.6%, with a complete response rate (CRR) of 85.2%. Patients had a median time to response of 1.0 month, and at a median follow-up of 7 months, 74.1% of patients continued to be in complete remission. The 6-month estimated progression-free survival rate was 83.2% (95% CI, 69.1%-100.0%).

Cytokine release syndrome (CRS) occurred in 96% of patients. 92% of CRS was of grade 1/2 and only 1 patient had grade 3 CSR. Immune effector cell-associated neurotoxicity syndrome occurred at grade 1 in 2 patients and no =grade 2 neurologic events reported in the study.