NCT05943067

CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT

A Multi-center Phase I/II Trial of Memory T Cell Donor Lymphocyte Infusions After Transplantation of CliniMACS® TCRα/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 8 Weeks – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to examine safety and toxicity of CD45RA depleted donor lymphocyte infusion (DLI) after transplantation of TCRα/β/CD19 depleted peripheral blood stem cells.

Detailed description

Patients will undergo routine reduced intensity conditioning regimen and intravenous infusion of T-cell receptor alpha/beta (TCRα/β)/CD19 depleted peripheral blood stem cells (not content of clinical trial). If no graft-versus-host disease (GVHD) occurs, patients receive the trial-related memory T cell donor lymphocyte infusion (DLI) on Day 30 after transplantation. In a dose finding part (phase I) escalating doses will be applied in cohorts of three (three plus three design) patients with a maximum of 18 patients for three dose levels (dose level 1-3). A fourth lower dose level (dose level 0) is started, if \>=2 out of 6 patients with dose level 1 develop aGVHD III/IV. The maximum tolerated dose (MTD) will be used for the confirmatory part (phase II) of the study.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
BIOLOGICAL	CD45RA depleted donor lymphocyte infusion (DLI)	CD45RA depleted donor lymphocyte infusion (DLI) after TCRα/β depleted haploidentical HCT

Timeline

• Start date: 2023-04-27
• Primary completion: 2028-01-01
• Completion: 2028-12-01
• First posted: 2023-07-13
• Last updated: 2025-04-27

Locations

2 sites across 1 country: Germany