A Phase 1 interventional study of Cellular therapy product in Allogeneic Stem Cell Transplant Candidate, Acute Myeloid/Lymphoblastic Leukemia and Myelodysplastic Syndrome, sponsored by Leland Metheny. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Leland Metheny · Phase 1, Interventional, and Treatment
The purpose of this study is to reduce the risk of cancer relapse by giving a donor lymphocyte infusion (DLI) to boost the immune system early after a stem cell transplant so that leukemia cells that escaped chemotherapy can be detected and killed. This DLI will contain mostly lymphocytes that have graft versus tumor effect with low risk of graft versus host disease. Because the process of giving a DLI in the first four weeks after a transplant has not been approved by the Food and Drug Administration (FDA), this study in investigational (experimental).
The primary objective of this study is to investigate if donor lymphocytes depleted of TCR-αβ T cells and B cells can be infused on Day 28 following allogeneic stem cell transplantation without inducing Grade III-IV graft versus host disease, Grade II GVHD requiring systemic treatment and or new onset, severe neutropenia requiring growth factor support.
This study also seeks to characterize the lymphocyte subsets obtained following depletion of TCR-αβ T cells and B cells from non-mobilized, leukapheresis products.
Additionally, this study will attempt to describe occurrence of disease relapse and to describe the occurrence of post-transplant re- activation and/or infections with viruses such as CMV, and EBV.
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Exclusion Criteria:
This study will treat 10 participants with the donor NK/TCR-γδ T cell product. Of those 10 participants, 5 would have 10/10 HLA matched sibling donors (MSD) while 5 would have partially matched, related (haplo) donors. * 27 days post transplant, the participant's donor will undergo a second, non-mobilized leukapheresis to obtain peripheral blood mononuclear cells (PBMCs). * Donor PBMCs will be processed next day (Day T+28) to obtain the NK cell/TCRγδ T cell product for same day infusion if the participant remains aGVHD free and clinically stable. * Participants will continue routine post-transplant and GVHD monitoring, as well as disease assessment at 56 days, 100 days, 6 months and 1 year following transplant. * Blood samples will be obtained on T=0, T+7, 14, 21 and 28 days and then weekly until T + 56 days, then on T+100 days, + 6 months and + 12 months. If immune-mediated adverse events occur (GVHD, CRS etc) additional blood samples will be obtained at onset and resolution.
Biological: Cellular therapy product
Cellular therapy product: Allogeneic transplant donor lymphocytes, depleted of TCR-αβ T cells and B cells; enriched for NK cells and TCRγδ T cells. * Infused using venous catheter on post-transplant Day 28 (+ 7 days). * Single infusion of entire lymphocyte product derived from two-blood volume leukapheresis (non-mobilized).
Incidence of Grade III-IV GVHD, Grade II GVHD requiring systemic treatment or new onset, severe neutropenia requiring growth factor support at Day 100 and T+6 months.
This study seeks to measure if donor lymphocytes depleted of TCR-αβ T cells and B cells can be infused on Day 28 following allogeneic stem cell transplantation without inducing Grade III-IV graft versus host disease, Grade II GVHD requiring systemic treatment or new onset, severe neutropenia requiring growth factor support. The endpoint associated with this objective is 'incidence of Grade III-IV graft versus host disease, Grade II GVHD requiring systemic treatment or new onset, severe neutropenia requiring growth factor support at Day 100 and T+6 months.'
Time frame: up to 30 days after lymphocyte product infusion
Different lymphocyte types in the infused product reported as cells per kilogram body weight of the recipient
Number of different lymphocyte types in the infused product measured as cells per kilogram body weight of the recipient
Time frame: 28 days post-transplant
Number of disease relapse events in the first 6 moths following stem cell transplant
To describe occurrence of disease relapse, the number of disease relapse events in the first year following stem cell transplant will be reported.
Time frame: 6 months from start of treatment
Number of disease relapse events in the first 1 year following stem cell transplant
To describe occurrence of disease relapse, the number of disease relapse events in the first year following stem cell transplant will be reported.
Time frame: 1 year from start of treatment
Average time to disease relapse from date of transplant
To describe occurrence of disease relapse, the average time to disease relapse from date of transplant in the first six months following stem cell transplant will be reported.
Time frame: 6 months from start of treatment
Average time to disease relapse from date of transplant
To describe occurrence of disease relapse, the average time to disease relapse from date of transplant in the first year following stem cell transplant will be reported.
Time frame: 1 year from start of treatment
Occurrence of reactivated Epstein Barr Virus (EBV) and/or Cytomegalovirus viremia (CMV) as measured by number of study subjects developing measurable viremia
To describe the occurrence of post-transplant re- activation and/or infections with viruses such as CMV, and/or EBV, the number of study subjects developing measurable viremia will be reported
Time frame: 6 months from start of treatment
Average time to first occurrence of reactivated EBV and/or CMV
To describe the occurence of post-transplant re- activation and/or infections with viruses such as CMV, and/or EBV, median time to first occurrence of reactivated EBV and/or CMV will be reported.
Time frame: 6 months from start of treatment
Plan to share: Yes — Individual participant data that underlie or influence the results observed from the study
Supporting information: Study protocol, Sap, Csr, Analytic code
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This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Leland Metheny