The FDA has granted CTX110 – an allogeneic CAR T-cell therapy that targets CD19+ B-cell malignancies – Regenerative Medicine Advanced Therapy designation, according to a recent press release, 

The CARBON phase 1 single-arm, multi-center, open-label clinical trial is ongoing and studying the safety and efficacy of CTX110 in patients with relapsed or refractory B-cell malignancies. Several doses of CTX110 are being evaluated in this trial.

“This RMAT designation is based on the encouraging clinical data we have presented thus far, and it is an important milestone that recognizes the transformative potential of CTX110 for the treatment of hematological malignancies,” said Samarth Kulkarni, PhD, Chief Executive Officer of CRISPR Therapeutics, in a press release. “We look forward to working closely with the FDA as we continue our efforts to bring this important new therapeutic modality to patients.”