China-based Cellular Biomedicine Group Inc. (CBMG), a private company following a merger deal in February last year, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib clinical study of its chimeric antigen receptor (CAR)-T cell therapy C-CAR039 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-cell NHL).
Therapy Details
C-CAR039 is a second-generation 4-1BB CAR-T therapy targeting CD19 and CD20. It has received orphan drug designation (ODD) for follicular lymphoma in the US in June 2021 and clinical approval the same December. In January of this year, the US FDA awarded it Regenerative Medicine Advanced Therapy (RMAT) designation and fast-track designation for treating relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Clinical Data
CBMG presented clinical data for C-CAR039 in r/r B-cell NHL at last year’s American Society of Clinical Oncology (ASCO) annual meeting, showing a good safety and efficacy profile. As of April 20, 2021, 34 patients had received C-CAR039. Cytokine release syndrome (CRS) occurred in 92.9% of patients, mostly grade 1 or 2, with only one case of grade 3. The overall response rate (ORR) was 92.6%, the complete response (CR) rate was 85.2%, the median time to response was one month, and the 6-month progression-free survival (PFS) rate was 83.2%.-Fineline Info & Tech
