FDA fast tracks CAR T-cell therapy for refractory lupus in anticipation of phase 1 trial
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Key takeaways:
- CB-010, an allogeneic anti-CD19 CAR T-cell therapy, will soon be evaluated in lupus nephritis and extrarenal lupus.
- The treatment features PD-1 knockout to prevent early CAR T-cell exhaustion.
The FDA has granted fast track designation to CB-010, an allogeneic anti-CD19 CAR T-cell therapy from Caribou Biosciences, for refractory systemic lupus erythematosus ahead of a planned phase 1 trial, according to a press release.
CB-010 will be evaluated in patients with lupus nephritis and extrarenal lupus as part of the GALLOP phase 1 clinical trial, which is expected to begin by the end of 2024.
“Based on previously reported data in our ongoing trial for patients with relapsed or refractory B-cell non-Hodgkin lymphoma, CB-010 has shown encouraging safety, efficacy and prolonged B-cell aplasia following a single dose,” Tina Albertson, MD, PhD, chief medical officer at Caribou, said in the release. “Based on these data, we are eager to expand the clinical development program for CB-010 into [lupus nephritis] and [extrarenal lupus], prevalent and severe autoimmune diseases.”
According to the company, CB-010 was designed with a PD-1 knockout, a genome-editing technique that limits premature CAR T-cell exhaustion and bolsters activity against disease.
In the same release, Caribou additionally announced that the FDA has also granted fast track designation to CB-012, the company’s allogeneic anti-CLL-1 CAR T-cell therapy, for patients with refractory acute myeloid leukemia. That treatment is currently being evaluated in the company’s ongoing AMpLify phase 1 clinical trial.
The FDA’s fast track designation is intended to hasten the development and review processes of prospective treatments that may address unmet medical needs. The designation allows for early and frequent communication with the FDA throughout the regulatory review process and may also qualify a treatment for accelerated approval and priority review when relevant criteria are met.
“We are pleased to receive fast track designations from the FDA,” Albertson said. “This is a testament to the significant unmet need and the potential of CB-010 and CB-012 as readily available, off-the-shelf CAR T-cell therapies.”
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