Study Design
Cancer
ONCOLOGY, CANCER
This is a non-parallel, pilot clinical trial that was performed as a non-randomized, non-blinded study. It is a multi-central trial that has been registered in the Iranian clinical trial data set (IRCT) coded IRCT20200621047859N3 on 30/12/2020 and achieved the ethics code before patient enrollment (IR.ACECR.IBCRC.REC.1398.015) 16/10/2019. There was no preference in the selection of patients for dose administration, and patient enrollment was done in chronological order and was performed on a timeline from the beginning of the project.This study was executed by Motamed Cancer Institute and Cell Therapy and Hematopoietic Stem Cell Transplantation Research Center of Shariati Hospital of Tehran University of Medical Sciences. Cell infusion was administered in the Department of Oncology of Imam Reza Hospital. NK cell chimerism was performed on days 2, 7, and 28 after infusion, as previously described [Due to the dose escalation evaluation, all patients were enrolled in cohorts of 5 per dose level. Both groups were selected based on the same inclusion criteria and treated with a unique conditioning regimen, and the PB-NK-cell product was administered at days 0 and + 7. Cohort 1 was initiated with an adoptive transfer dose of 2 × 10