FDA grants RMAT designation to natural killer cell therapy for advanced lymphoma
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The FDA granted regenerative medicine advanced therapy designation to FT516, a natural killer cell therapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
FT516 (Fate Therapeutics) is gene-edited, allogeneic, induced pluripotent stem cell-derived natural killer (NK) cell therapy.
Researchers engineered the investigational agent to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent downregulation and enhance binding to tumor-targeting antibodies, according to the manufacturer.
The FDA based the regenerative medicine advanced therapy (RMAT) designation on results of an ongoing phase 1/phase 1B clinical trial. The dose-escalation/dose-expansion study is designed to assess the safety and efficacy of FT516 in combination with rituximab (Rituxan, Genentech) for adults with relapsed or refractory B-cell lymphoma.
Results from the dose-escalation portion of the study, presented at this year’s ASH Annual Meeting and Exposition, showed an 80% response rate among 10 patients who did not receive prior chimeric antigen receptor T-cell therapy.
Eleven patients (61%) in the second, third and fourth dose levels responded to therapy and had continuing response of at least 3 months after infusion with FT516. Eight of these patients (44%) had an ongoing response to therapy as of the data cutoff date, with median follow-up of 8.3 months.
Researchers identified infections as the most frequent treatment-related adverse events. No cases of cytokine release syndrome, neurotoxicity or graft-versus-host disease occurred during the dose-escalation portion of the study.
“We continue to be highly encouraged by the differentiated therapeutic profile of FT516 as an off-the-shelf NK cell therapy administered in the outpatient setting, and its potential to deliver deep and durable responses for patients with advanced B-cell lymphomas, including those [who] have received prior autologous CAR T-cell therapy,” Wayne Chu, MD, senior vice president of clinical development at Fate Therapeutics, said in a company-issued press release.
Fate Therapeutics has begun enrolling patients into one of several cohorts for the dose-expansion stage of the study at a dose of 9 × 108 cells.
“The RMAT designation for the treatment of relapsed or refractory [diffuse large B-cell lymphoma] reflects the positive clinical data we have observed with FT516 in the dose-escalation stage of our phase 1 study,” Chu said. “We look forward to working closely with the FDA to accelerate the development of FT516 in this area of significant unmet medical need with the goal of expanding the reach of transformative cell therapies.”
The FDA’s RMAT designation program, part of the 21st Century Cures Act, expedites review of regenerative medicine therapies intended to treat, modify, reverse or cure serious or life-threatening diseases or conditions. Preliminary clinical evidence must indicate the therapy has the potential to address unmet medical needs.
Reference:
Patel K, et al. Abstract 3873. Presented at: ASH Annual Meeting and Exposition; Dec. 11-14, 2021.
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