NCT03836690

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Phase I study using a Bayesian Time-to-Event Continual Reassessment Method (CRM) to determine safety and maximum tolerated dose (MTD) of CD62L- Tem. Eligible patients and HLA-identical sibling donors will be registered prior to stem cell transplant (SCT). Donors will undergo an additional steady state apheresis for the collection of T cells between day -14 and day +24 of the allo-SCT according to logistics. Selection of Tem at the required dose will be performed at UCL Centre for Cell, Gene and Tissue Therapeutics (CCGTT) before distribution of the cryopreserved cells to the trial centre. Doses of Tem selected and infused will be: 1x10\^5, 3x10\^5, 1x10\^6 or 3x10\^6. Donor Tem will be infused on day 24-32 following allo-SCT. Patients will be followed-up for 12 months with specific evaluation points just prior to Tem infusion and at 3, 6, 9 and 12 months following allo-SCT.

Conditions

• Lymphoma
• Leukemia
• Myeloma
• Myelodysplastic Syndromes
• Severe Aplastic Anemia
• Primary Immune Deficiency
• Graft Vs Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	CD62L- Tem	Donor memory T cells that have been depleted of CD62L+

Timeline

• Start date: 2019-10-21
• Primary completion: 2022-07-01
• Completion: 2023-04-01
• First posted: 2019-02-11
• Last updated: 2019-10-25

Locations

1 site across 1 country: United Kingdom