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Celularity Announces Clinical Data on Human Placental-Derived Unmodified Allogeneic Natural Killer Cell Therapy Candidate Cynk-001 in Adult Patients With Relapsed Refractory and Measurable Residual Disease-Positive Acute Myeloid Leukemia
In patients with relapsed refractory acute myeloid leukemia (R/R AML) treated with a four-dose regimen consisting of 1.8 billion CYNK-001 cells per dose, two
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[{"type":"text","content":"In patients with relapsed refractory acute myeloid leukemia (R/R AML) treated with a four-dose regimen consisting of 1.8 billion CYNK-001 cells per dose, two of four patients achieved an objective response at Day 28 In patients with measurable residual disease-positive (MRD positive) AML treated with a three-dose regimen consisting of 1.8 billion CYNK-001 cells per dose, one of three patients achieved MRD negativity Treatment with CYNK-001 was generally well-tolerated, with no observed dose-limiting toxicities, even at the highest dose These results provide a strong basis to conclude this study and optimize the treatment protocol in the design of the next trial employing Celularity’s next-generation genetically modified natural killer (NK) cell therapy candidate in AML, CYNK-301 FLORHAM PARK, N.J., April 27, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, today announced preliminary results from its Phase 1 trial of CYNK-001, its investigational unmodified natural killer (NK) cell therapy in development for the treatment of R/R AML and MRD positive AML. Cohort 6B of the Phase 1 trial was comprised of patients with heavily pre-treated R/R AML who received a four-dose regimen consisting of 1.8 billion CYNK-001 cells per dose following enhanced lymphodepletion. Of these, two of four patients achieved an objective response, defined as a morphological leukemia-free state, or MLFS. Cohort 4A of the Phase 1 trial was comprised of patients with MRD positive AML. Of these, one of three patients achieved MRD negativity after treatment with a three-dose regimen consisting of 1.8 billion CYNK-001 cells per dose following enhanced lymphodepletion. Based on preliminary analysis of the Phase 1 trial data, this trial will now be closed to further enrollment as Celularity refines the trial design for subsequent studies with a next-generation NK product candidate. Celularity will continue to follow up with the trial participants. Treatment with CYNK-001 showed biological activity and was generally well-tolerated, with no dose-limiting toxicities observed with even the highest dose of CYNK-001. This trial also yielded important insights into the optimal approach to lymphodepletion, the role of IL-15 and IL-2 in NK-cell persistence, and...