Caribou gets FDA fast track for allogeneic CAR-T

Caribou Biosciences is a biopharma company that has proprietary chRDNA (CRISPR hybrid RNA-DNA) technology, which allows for the creation of genome-edited cell therapies. One of the products of this technology, CB-011, was provided Fast Track designation by the US Food and Drug Administration (FDA).

The treatment candidate is being evaluated in Phase I clinical trials for relapsed or refectory multiple myeloma (r/r MM). CB-011 itself is an allogeneic anti-BCMA CAR-T therapy that was created through Cas12a chRDNA technology.

According to Caribou, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to improve antitumor activity through an immune cloaking strategy, with a B2M knockout and insertion of B2M-HLA-E fusion protein to reduce immune-mediated rejection.

The phase 1 clinical trial into the potential treatment plans to enroll 50 participants, with an estimated study completion date of February 2027.

“Fast Track designation for CB-011 allows us instrumental interactions with the FDA as we progress our clinical development and regulatory plans for CB-011. This designation could not be more timely as we recently dosed our first patient in the CaMMouflage Phase I trial,” said Syed Rizvi, Caribou’s chief medical officer.

The news of the first patient being dosed in the trial was announced at the end of March 2023. The patient received CB-011 at a dose level of 50×106​ CAR-T cells, with the aim of the trial being to assess the safety of the drug candidate and to determine how its immune cloaking approach could improve antitumor activity.

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