NCT07285668

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

Phase I Study of Prophylactic TCRαβ+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives * To assess safety of prophylactic TCRαβ+/CD19+ depleted donor lymphocyte infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies * To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of αβT/B dep-DLI Secondary Objectives * To assess the feasibility of αβT/B dep-DLI * To assess additional safety parameters after αβT/B dep-DLI * To assess the efficacy of αβT/B dep-DLI For the dose escalation phase: Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD) is defined as the highest dose level where less than 2 of 6 participants experience a dose limiting toxicity (DLT). Each dose level will be followed for DLTs until day 28 post donor lymphocyte infusion (DLI). Starting at dose level 1: * If 0 of 3 participants experiences DLT, increase to next dose level for next 3 participants. * If 1 of 3 participants experience DLT, enroll 3 participants at same dose level. * If no additional DLTs (1 of 6), move on to next dose level. * If 2 of 6 participants experience DLT, enroll 3 participants into lower dose level. * If 0 or 1 participants experience DLT at lower level, this will be the MTD. Once the MTD or MAD is determined, an expansion cohort will be enrolled into that dose level. All participants will be followed for 2 years after DLI.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-26
• Primary completion: 2029-02-01
• Completion: 2031-02-01
• First posted: 2025-12-16
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study