Posted: Friday, February 26, 2021
James McCloskey, MD, of Hackensack University Medical Center, New Jersey, and colleagues evaluated the use of CYNK-001—a cryopreserved allogeneic, off-the-shelf natural killer cell investigational product derived from placental CD34-positive cells—in select patients with acute myeloid leukemia (AML). At the 2021 Transplantation & Cellular Therapy Meetings (TCT), these investigators presented their overview of the ongoing CYNK-001-AML-001 trial (Abstract 173).
In a previous phase I trial, PNK-007, a fresh formulation comparable to CYNK-001 was administered as a single infusion of up to 106 cells/kg to patients with relapsed or refractory AML. The treatment was deemed safe, with one treatable event of cytokine-release syndrome, and a clinical response was achieved in 2 of 10 patients.
The ongoing trial will enroll up to 16 patients who are in morphologic complete remission (with or without hematologic recovery) and have minimal residual disease (MRD). Placental CD34-positive cells have been cultivated in the presence of cytokines to generate CYNK-001. Following 300 mg/m2 of lymphodepletion with cyclophosphamide and 25 mg/m2 of fludarabine, participants will be administered three infusions of either 600 million, 1.2 billion, or 1.8 billion cells using a 3+3 design. Transplant-eligible patients may receive their transplant as indicated once the 28-day dose-limiting toxicity period is complete and their MRD status is identified.
Safety will be evaluated by the frequency and severity of adverse events using a non–weight-based dose of CYNK-001. Efficacy will be determined by the duration of and time to MRD response, MRD conversion rate, duration of morphologic complete remission, and progression-free and overall survival.
At the time of abstract presentation, one MRD-positive patient with intermediate-risk AML in morphologic complete remission had received three doses of 600 million cells following consolidation/induction with azacitidine and venetoclax. This patient is currently in follow-up and is reported to have tolerated CYNK-001 well, without dose-limiting toxicities.
Disclosure: For full disclosures of the study authors, visit tct.confex.com.