Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07285668
Status
Recruiting
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Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Dec 16, 2025
Start date
Feb 26, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2031

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort Level 1
    1 x 10\^6 CD3-CD56+/kg
  • Experimental: Dose Escalation Cohort Level 2
    2 X 10\^6 CD3-CD56+/kg
  • Experimental: Dose Escalation Cohort Level 3
    5 X 10\^6 CD3-CD56+/kg
  • Experimental: Dose Escalation Cohort Level -1
    0.5 x 10\^6 CD3-CD56+/kg Dose to be used only if Dose Level 1 is not tolerated.

Primary Outcome Measure

Incidence of Adverse Events (AEs) from DLI to day 28 post-DLI [ Time Frame: up to day 28 post-DLI (approximately day 63 on study) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UW Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Madison, WI

By research site
UW Carbone Cancer Center· Madison, WI

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