Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
NCT07285668 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2026-04-03
Summary
This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte Infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in highrisk patients with hematologic malignancies.
Conditions
Interventions
- DEVICE
-
Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Single intravenous dose of allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells (i.e., αβT/B dep-DLI), where the dose is based on the natural killer (NK) cell (CD3-CD56+) content in the DLI product. Each participant will receive one of four DLI doses depending upon cohort to which the participant is enrolled.
Sponsors & Collaborators
-
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Jacques Galipeau, MD, FRCP(C) · UW School of Medicine and Public Health
-
Hongtao Liu, MD, PhD · UW Carbone Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-26
- Primary Completion
- 2029-02-28
- Completion
- 2031-02-28
- FDA Device
- Yes
Countries
- United States
Study Locations
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