Clinical Trial

Phase I

The safety and efficacy of anti-MiHA donor T-lymphocytes expanded ex vivo (GLIDE T-lymphocytes) are currently evaluated in a multicenter single-arm Phase 1 trial in patients with a hematologic malignancy who have relapsed after AHCT.

A follow-up Phase 2 multicenter, controlled, randomized trial in patients with myeloid leukemia is planned. The trial will measure the efficacy of GLIDE T-lymphocytes by comparing the progression-free survival at 12 months (PFS 12m) in patients who have received an AHCT followed with a GLIDE T-lymphocytes infusion with the PFS 12m in patients treated have received an AHCT only.

Description

The GLIDE-201/44 trial primarily aims to test the safety of GLIDE T-lymphocytes in patients suffering from a hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor. The GLIDE T-lymphocytes are derived from the original donor. Both the patient and the matched donor will undergo screening to determine the expression of targetable MiHAs. Upon identification of the target MiHAs, donor cells will be collected through apheresis and primed against the selected MiHA. GLIDE T-lymphocytes will then be administered to the patient.

This study is sponsored by Centre intégré universitaire en santé et en services sociaux de l’Est-de-l’Ile-de-Montréal.
 For more information please contact Mr. Jean-Guy Némorin, Ph.D., at  514 252-3400 x 6247 or via email: jgnemorin@pcitp.org