Clinical trial: Relapsed or Refractory Acute Myeloid Leukemia, AML, (NCT06541444)

Cancer research · Acute myeloid leukemia

The combination of venetoclax with cytarabine and daunorubicin or venetoclax with azacitidine is being evaluated for improved outcomes in newly diagnosed AML patients compared to standard cytarabine + daunorubicin.

This open‑label, single‑arm, Phase I‑III study aims to assess the safety and efficacy of allogenic NK cells that have been genetically engineered via AccuBase™ base editor to knock out PD‑1 and knock‑in CD16. NK cells will be infused once a week; investigators will monitor dose‑limited toxicity, determine maximum tolerated dose, and provide dosing guidance for future trials.

Patients with relapsed or refractory AML have limited treatment options and poor prognosis. Gene‑edited NK cells that lack PD‑1 inhibitory signals and express CD16 to enhance antibody‑dependent cellular cytotoxicity may offer a novel, potentially curative immunotherapy approach for this high‑need patient population.

Evidence level: Korai humán adat. Kis vagy feltáró emberi adat.

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