Trial | NCT02385019  Report issue

Official Title

A Phase 1/2 Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    22
Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host disease after an allogeneic transplant of hematopoietic progenitors with donor CliniMACS-selected regulatory T cells
Phase 1/2 clinical study evaluating safety (Phase 1) and preliminary efficacy (Phase 2) of donor regulatory T cells for patients with steroid-refractory chronic graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT).

Patients must have persistent signs and symptoms despite the use of prednisone or equivalent at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day), for at least 4 weeks without complete resolution of signs and symptoms. Occasional patients requiring lower doses of prednisone will be eligible if associated with other immunosuppressive drugs.

Phase 1 clinical trial will include groups of 5 patients sequentially treated with: 0.5 x 10ˆ6, 1.0 x 10ˆ6, 2-3 x 10ˆ6 donor Treg/kg. Phase 2 clinical trial will include another 5 to 10 patients treated with MTD.

Donor Treg will be selected by the following sequential steps:

- negative depletion of CD8 and CD19 cells
- positive selection of CD25 cells
Study Started
Mar 31
2015
Primary Completion
Mar 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Mar 06
2018

Biological Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease

Regulatory T cells selected by a sequential 2 step procedure: - Negative selection of CD8 and CD19 cells - Positive selection of CD25 cells

Administration of 0.5 x 10ˆ6 donor Treg/kg Experimental

First group of 5 patients will receive a total of 0.5 x 10ˆ6 donor Treg/kg. Part of Phase 1 study.

Administration of 1.0 x 10ˆ6 donor Treg/kg Experimental

Second group of 5 patients will receive a total of 1.0 x 10ˆ6 donor Treg/kg. Part of Phase 1 study.

Administration of 2.0-3.0 x 10ˆ6 donor Treg/kg Experimental

Third group of 5 patients will receive a total of 2.0-3.0 x 10ˆ6 donor Treg/kg. Part of Phase 1 study.

Administration of MTD of donor T reg Experimental

Preliminary Phase 2 study will include another 5 to 10 patients at the MTD identified in the Phase 1 study

Criteria 

Inclusion Criteria:

Patients must have persistent signs and symptoms despite the use of prednisone or equivalent at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day), for at least 4 weeks without complete resolution of signs and symptoms. Occasional patients requiring lower doses of prednisone will be eligible if associated with other immunosuppressive drugs.
Stable immunosuppressive medication in the 4 weeks prior to initiation of treatment
PS 0-2 ECOG
Adequate liver, kidney, lung and hematopoietic system functions

Exclusion Criteria:

Pediatric patients
Pregnant women
Ongoing prednisone requirement >1 mg/kg/day (or equivalent)
Concurrent use of calcineurin-inhibitor plus sirolimus (either agent alone is acceptable)
New immunosuppressive medication in the 4 weeks prior
Extra-corporeal Photopheresis or rituximab therapy in the 4 weeks prior
Exposure to T-cell or IL-2 targeted medication (e.g. ATG, alemtuzumab, basiliximab, denileukin diftitox) within 100 days prior
Donor lymphocyte infusion within 100 days prior
Active malignant relapse
Active uncontrolled infection
HIV-infected patients
No Results Posted