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Results of a phase I trial with Haploidentical mbIL‐21 ex vivo expanded NK cells for patients with multiply relapsed and refractory AML
Ist Teil von
American journal of hematology, 2024-05, Vol.99 (5), p.890-899
Ort / Verlag
Hoboken, USA: John Wiley & Sons, Inc
Erscheinungsjahr
2024
Quelle
MEDLINE
Beschreibungen/Notizen
Natural killer (NK)‐cells have potent anti‐tumor effects, yet it remains unclear if they are effective for patients with relapsed acute myeloid leukemia (AML). In a phase I clinical trial, we treated 12 patients (median age 60 years) with refractory AML (median 5 lines of prior therapy, median bone marrow blast count of 47%) with fludarabine/cytarabine followed by 6 infusions of NK‐cells expanded from haploidentical donors using K562 feeder cells expressing membrane‐bound IL21 and 4‐1BBL. Patients received 106–107/kg/dose. No toxicity or graft‐versus‐host disease (GVHD) was observed and MTD was not reached. Seven patients (58.3%) responded and achieved a complete remission (CR) with/without count recovery. Median time to best response was 48 days. Five responding patients proceeded to a haploidentical transplant from the same donor. After a median follow‐up of 52 months, 1‐year overall survival (OS) for the entire group was 41.7%, better for patients who responded with CR/CRi (57.14%), and for patients who responded and underwent transplantation (60%). Persistence and expansion of donor‐derived NK‐cells were identified in patients' blood, and serum IFNγ levels rose concurrently with NK cell infusions. A higher count‐functional inhibitory KIR was associated with higher likelihood of achieving CR/CRi. In conclusion, we observed a significant response to ex vivo expanded NK‐cell administration in refractory AML patients without adverse effects.
Swimmer plot of patients treated on clinical trial and CF‐iKIR scores.