NCT05066412

Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.

Detailed description

Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning. Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen. Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation.

Conditions

• Hematologic Malignancy
• Haplo-identical Stem Cell Transplantation

Interventions

Type	Name	Description
OTHER	CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology	CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology

Timeline

• Start date: 2024-11-26
• Primary completion: 2026-06-02
• Completion: 2026-12-02
• First posted: 2021-10-04
• Last updated: 2025-02-13

Locations

1 site across 1 country: Switzerland