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Caribou Biosciences reports CB-010 ANTLER Phase 1 trial progress
The Fly

Caribou Biosciences reports CB-010 ANTLER Phase 1 trial progress

Caribou Biosciences reported new 12-month clinical data from cohort 1 in the ongoing ANTLER Phase 1 trial, which show long-term durability following a single infusion of CB-010 at the initial dose level 1. Cohort 1 results show: 6 of 6 patients achieved a complete response as best response; 3 of 6 patients maintained a durable CR at 6 months; 2 of 6 patients maintain a long-term CR at the 12 month scan and remain on the trial; 18 months is the longest CR maintained to date in ANTLER, achieved by the first patient dosed with CB-010; CB-010 was generally well tolerated with adverse events consistent with autologous or allogeneic anti-CD19 CAR-T cell therapies; Based on promising initial data, the U.S. Food and Drug Administration granted CB-010 both Regenerative Medicine Advanced Therapy and Fast Track designations. In addition, Caribou has observed an encouraging safety profile for CB-010 at dose level 2 with no dose-limiting toxicities in the 3 patients treated and is currently enrolling patients at dose level 3. Caribou expects to provide an ANTLER trial update in 2023. ANTLER is a Phase 1, open-label, multicenter clinical trial evaluating the safety and efficacy of the company’s lead allogeneic cell therapy, CB-010, in patients with r/r B-NHL. The trial includes Part A, a 3+3 dose escalation phase designed to evaluate safety of CB-010 at multiple dose levels and establish the recommended Phase 2 dose, and Part B, a dose expansion phase with the primary objective to determine tumor response after a single dose of CB-010. As permitted by the protocol, backfilling patients has begun at doses deemed well tolerated to increase the understanding of CB-010’s safety profile and antitumor activity and provide additional data for establishing a recommended Phase 2 dose.

Published first on TheFly

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