NCT03939585

Preemptive Infusion of Donor Lymphocytes Depleted of TCR + T Cells + CD19+ B Cells Following ASCT

Preemptive Infusion of Donor Lymphocytes Depleted of TCR (Alpha-beta) + T Cells and CD19+ B Cells Following Allogeneic Stem Cell Transplantation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Leland Metheny · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Allogeneic Stem Cell Transplant Candidate
• Acute Myeloid/Lymphoblastic Leukemia
• Myelodysplastic Syndrome
• Myeloproliferative Neoplasm
• Lymphoproliferative Disorders

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2019-05-07
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study