The U.S. Food and Drug Administration (FDA) approved C-CAR039, a new autologous bi-specific CAR-T therapy for the treatment of patients with relapsed or refractory diffuse large B cell lymphoma (r/r DVBCL), according to Cellular BioMedicine Group (CMBG).

The agency granted the therapy Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation for the treatment of relapsed or refractory diffuse large B cell lymphoma.

Cellular BioMedicine is a biopharmaceutical company that develops innovative cellular immunotherapies for the treatment of cancer.

Tony Liu, CEO of Cellular BioMedicine, said, “This is great news for CBMG that the FDA has granted C-CAR039 both RMAT and fast track designations based on its potential to increase objective and complete response rates in r/r DLBCL.”

“The clinical data based on our clinical trials in China continue to support the hypothesis that C-CAR039 is the best-in-class CAR-T asset for patients in this indication,” he added. “We are working towards initiating 1b/2 trials for C-CAR039 in the US soon. And we will work closely with the FDA to seek the best path forward to deliver the drug to patients in the US and EU.”

Early clinical trials conducted across China have demonstrated promising efficacy and considerable safety data of C-CAR039 in treating r/r DLBCL. As of April 2021, 34 patients received C-CAR039 cell therapies. The best overall response rate (ORR) was reported to be 92.6%.

Just over 74% of patients continued to be in complete remission. The 6-month progression-free survival rate was 83.2%.

Cytokine release syndrome (CRS) was seen in 96% of patients. Some patients had immune effector cell-associated neurotoxicity syndrome. CBMG will continue to evaluate patients with longer follow-up.

Headquartered in Shanghai, China, CBMG develops proprietary cell therapies for cancer as well as degenerative diseases. The company operates a state-of-the-art facility in Rockville, Maryland to boost its global research and development capabilities and to support the clinical development of cell therapy technologies in the United States.