CBMG Announces FDA Grants Regenerative Medicine Advanced Therapy and Fast Track Designations to C-CAR039, a Novel Bispecific Anti-CD19/CD20 CAR-T Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

On January 12, 2022, Cellular Biomedicine Group announced that the U.S. FDA granted C-CAR039 Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track status for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). C-CAR039 is a novel autologous bispecific CAR-T cell therapy that simultaneously targets CD19 and CD20 antigens, effectively eliminating CD19/CD20 single-positive or double-positive tumor cells both in vivo and in vitro. In June 2021, the FDA also granted C-CAR039 Orphan Drug designation for the treatment of follicular lymphoma (an indolent non-Hodgkin lymphoma), and in December of the same year, approved the IND application for C-CAR039.

DLBCL is an aggressive non-Hodgkin lymphoma (NHL) and the most common histological subtype of NHL. Previously, a clinical trial initiated by researchers in China demonstrated that C-CAR039 treatment for relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-cell NHL) showed good safety and encouraging clinical efficacy.

Specifically, as of April 20, 2021, a total of 34 patients had received C-CAR039 cell therapy. These patients had previously undergone a median of 3 lines of treatment, with a median age of 55.5 years, and 75% of the cancers were at Ann Arbor stage III/IV. Among them, 28 patients were available for safety analysis, and 27 patients were available for efficacy analysis. The trial results showed that the overall response rate (ORR) was 92.6%, and the complete response (CR) rate reached 85.2%. At the median follow-up of 7 months, 74.1% of the patients still maintained CR. The 6-month progression-free survival rate was 83.2%.

In terms of safety, 92.9% (n=26/28) of patients experienced cytokine release syndrome (CRS), with 2 patients (n=2/26) developing grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS). Cellular Biomedicine Group (Shanghai) Ltd will continue to evaluate patients with longer follow-up times.

References:

[1] CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations for Bi-Specific Anti-CD19/CD20 CAR-T Cell Therapy for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma. Retrieved January 12, 2022, from https://www.prnewswire.com/news-releases/cbmg-receives-fda-regenerative-medicine-advanced-therapy-and-fast-track-designations-for-bi-specific-anti-cd19cd20-car-t-cell-therapy-for-relapsedrefractory-b-cell-non-hodgkin-lymphoma-301459134.html

(Original text has been abridged)

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