drugset / Trial / NCT03836690

Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation

NCT03836690 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Following stem cell transplantation, a major risk is graft-versus-host disease (GVHD). This occurs when donor immune cells that have been infused recognise the host's cells as 'foreign' and attack these cells. Prevention of GVHD relies upon depletion of donor immune T cells or drugs that block T cell function. However, these methods also increase the risk of life threatening infection. There is an important unmet need for better means of accelerating immune recovery following stem cell transplantation while avoiding GVHD. Pre-clinical studies have shown that infusion of donor CD62L- effector memory T cells (Tem) into the host improve immune recovery after allo-Stem Cell Transplant but do not cause GVHD. PURPOSE: This phase I dose escalation trial aims to determine the feasibility and safety of transfer of donor Tem following allogeneic stem cell transplantation.

Timeline

Start
2019-10-21
Primary completion
2022-07-01
Completion
2023-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CD62L- Tem Cell therapy 100000 cells —
Subject CD62L- Tem Cell therapy 300000 cells —
Subject CD62L- Tem Cell therapy 1e+06 cells —
Subject CD62L- Tem Cell therapy 3e+06 cells —