eClinical Technology and Industy News

Caribou Biosciences Provides Regulatory Update on CB-010 Pivotal Plan with Phase 3 Trial Initiation Expected by YE 2024

Caribou met with the FDA and reached alignment on a pivotal trial in 2L LBCL with CB-010 versus a comparator arm of immunochemotherapy followed by HDCT and ASCT —

— ANTLER Phase 1 trial continues dose expansion enrollment; initial dose expansion data and RP2D expected Q2 2024 —

— Caribou plans to initiate Phase 3 pivotal trial by YE 2024 —

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BERKELEY, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) — Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today provided an update based on feedback from the U.S. Food and Drug Administration (FDA) following recent communications and a Type B clinical meeting regarding the CB-010 development program. The company has received the FDA’s feedback on a Phase 3 randomized controlled trial for CB-010, an allogeneic anti-CD19 CAR-T cell therapy in development for patients with second-line relapsed or refractory large B cell lymphoma (r/r LBCL). The FDA stated that Caribou’s proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is acceptable.

“FDA feedback on our CB-010 pivotal development plan represents an important step in advancing our lead therapy to enable broader access of CAR-T cell therapies for patients living with large B cell lymphoma,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “As our ongoing ANTLER trial progresses, we look forward to engaging again with the FDA ahead of initiating our planned Phase 3 pivotal trial. Our goal is to establish a new second-line standard of care by delivering an off-the-shelf CAR-T cell therapy to patients as expeditiously as possible.”

In the ongoing ANTLER Phase 1 trial, Caribou is enrolling second-line LBCL patients in the dose expansion portion based on promising data from the dose escalation portion of the trial. Currently, 22 sites are active in the U.S. and the first international site is active in Australia, with additional site activation underway in the U.S. and globally. To Caribou’s knowledge, CB-010 is the first anti-CD19 allogeneic CAR-T cell therapy to be evaluated in the second-line LBCL setting and it has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations by the FDA.

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