Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentica… (NCT06158828) | Clinical Trial Compass
RecruitingPhase 1/2
Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML
United States68 participantsStarted 2024-11-15
Plain-language summary
This trial represents a single institution phase I/II pilot study with the primary objective of establishing the safety and feasibility of generating and infusing ML NK cells after TCRαβ haplo-HCT.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. High risk acute myeloid leukemia (AML) in either:
✓. Complete remission (CR) defined by \< 5% marrow blasts by morphology in the context of hematological recovery (ANC ≥ 0.5× 10\^9/L, platelet count ≥ 50 × 10\^9/L).
✓. Morphological leukemia free state (MLFS) defined by the absence of hematological recovery and \< 5% marrow blasts by morphology
✓. Patients must further meet one of the below for inclusion into the study:
✓. De novo AML in CR1 with any of the following high-risk features:
✓. De novo AML in ≥ CR2
✓. Therapy-related AML in CR1
✓. AML evolving from myelodysplastic syndrome (MDS)
Exclusion criteria
✕. Active GvHD. If patient had prior GvHD, patient must be off immunosuppression for at least 3 months prior to starting study treatment.
✕. Active non-hematologic malignancy. History of other malignancy is acceptable as long as therapy has been completed and there is no current evidence of disease.
✕. Currently receiving any other investigational agents at the time of transplant.
✕. Active CNS or extramedullary disease. History of CNS or extramedullary disease currently in remission is acceptable.
What they're measuring
1
Safety of patients being administered donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplant
Timeframe: From transplant through Day +100
2
Feasibility of manufacturing and administering donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplant
Timeframe: Through time of ML NK cell infusion (around Day +7)
. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
✕. Inability to discontinue medications that are likely to interfere with ML NK cell activity, i.e., glucocorticoids and other immunosuppressants.
✕. Presence of significant anti-donor HLA antibodies per institutional standards. Anti-donor HLA - Antibody Testing is defined as a positive crossmatch test of any titer (by complement dependent cytotoxicity or flow cytometric testing) or the mean fluorescence intensity (MFI) of any anti-donor HLA antibody by solid phase immunoassay \> 3000.
✕. Presence of a second major disorder deemed a contraindication for HCT.