Research & Development
Caribou Biosciences Wins FDA Clearance of its IND for CB-010, an Off-the-shelf Allogeneic Anti-CD19 CAR-T Cell Therapy
14 September 2020 - - The US Food and Drug Administration has cleared US-based CRISPR genome editing company Caribou Biosciences, Inc's Investigational New Drug application for CB-010, an off-the-shelf allogeneic anti-CD19, genome-edited CAR-T cell therapy for patients with relapsed/refractory B cell non-Hodgkin lymphoma (B-NHL), the company said.

Upon initiation of the ANTLER Phase 1 trial, CB-010 will be Caribou's first clinical-stage product candidate. CB-010 is manufactured from healthy donor T cells using Caribou's next-generation CRISPR genome editing technology.

Through genome editing, PD-1 is deleted from the CAR-T cells, which in preclinical studies promoted an increase in the durability of antitumor activity.

Genome editing is used to remove the endogenous T cell receptor in order to prevent graft-versus-host disease and to site-specifically insert the CAR into the CAR-T genome.

ANTLER is an open-label study designed to evaluate the safety and efficacy of a single dose of CB-010 in adult patients with different subtypes of relapsed/refractory B-NHL.

The study will be conducted at multiple clinical trial sites in the United States, and enrollment is expected to begin later this year.

Caribou is a company in CRISPR genome editing founded by pioneers of CRISPR biology.

The company is developing an internal pipeline of off-the-shelf allogeneic CAR-T cell therapies and genome-edited natural killer cell therapies.