Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML

Phase 1

Recruiting

• Conditions: Aml; Acute Myeloid Leukemia, Pediatric; Acute Myeloid Leukemia; AML, Childhood
• Interventions: Drug: Plerixafor; Biological: Granulocyte Colony-Stimulating Factor

• Registration Number: NCT06158828
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-06
• Study Start: 2024-05-15
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-06
• Last Update Posted: 2025-08-12
• Primary Completion: 2028-09-15
• Study Completion: 2030-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donor	Plerixafor	Donors who meet the eligibility criteria will be mobilized as per institutional standard practice using G-CSF 10 mcg/kg/day for 5 consecutive days. Leukapheresis will be performed after 5 days of G-CSF administration (on Day -1) with a target volume for collection of 20 liters. If additional collection days are necessary to ensure target CD34+ doses, G-CSF administration may be extended per institutional standard and adjusted per physician discretion. Up to 4 days of pheresis are permitted.
Donor	Granulocyte Colony-Stimulating Factor	Donors who meet the eligibility criteria will be mobilized as per institutional standard practice using G-CSF 10 mcg/kg/day for 5 consecutive days. Leukapheresis will be performed after 5 days of G-CSF administration (on Day -1) with a target volume for collection of 20 liters. If additional collection days are necessary to ensure target CD34+ doses, G-CSF administration may be extended per institutional standard and adjusted per physician discretion. Up to 4 days of pheresis are permitted.

Primary Outcome Measures

Name	Time	Method
Safety of patients being administered donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplant	From transplant through Day +100	Safety will be determined by events occurring following transplant. Non-relapse mortality, engraftment failure, and development of severe GvHD will be considered events.
Feasibility of manufacturing and administering donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplant	Through time of ML NK cell infusion (around Day +7)	Feasibility is defined by product manufacture failure, i.e., the inability to infuse ML NK cells due to product contamination or insufficient cell dose (\<0.5x10\^6 / kg recipient weight).

Secondary Outcome Measures

Name	Time	Method
Development of acute graft versus host disease (aGvHD)	From transplant through Day +100	Incidence of grade II, III, or IV acute GvHD as graded according to the NIH consensus criteria. Severe aGvHD (Grades III-IV) is considered an event.
Analysis of immune reconstitution	From transplant through Month 24	Immune reconstitution is defined as regain of function of donor-derived immunogenic cells and is measured by recovery of individual cellular compartments.
Relapse Free Survival (RFS)	From transplant through Month 12	Defined as the time between the date of transplant and date of last follow up, relapse, or death due to any cause.
Development of chronic graft versus host disease (cGvHD)	From transplant through Day +365	Incidence and severity of chronic GvHD as graded according to the NIH consensus criteria. Severe cGvHD is considered an event.
Overall Survival (OS)	From transplant through Month 12	Defined as death from any cause following transplant.
Development of infections	From transplant through Day +180	Significant infections include, but are not limited to, bacterial or fungal sepsis, viral reactivation with or without clinical disease, other viral infections, and community acquired infections.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States