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GLIDE single infusion at a target dose of 4x107 viable T-cells/m2

Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line

GLIDE

Jean-Guy Némorin, PhD

Stéphanie Thiant, PhD

Denis-Claude Roy, MD PhD

Jean-Sébastien Delisle, MD PhD

Silvy Lachance, MD

This study will evaluate the safety of infusing an anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor.

The GLIDE-201/44 trial primarily aims to test the safety of anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor. The anti-MiHA T cell lines are derived from the matched donor for the patient, the original donor for a given patient. 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. In this setting, the GLIDE 201/44 product will be cryopreserved, thawed and administered as a single infusion at a target dose of 4x10E+07 viable T cells/m2 (range of dose is 0.4 4x10E+07 viable T cells/m2). A second infusion can be offered to the patients after an observation period of 42 days upon clinical evaluation by the treating physician. In the absence of secondary adverse events following the initial infusion, a second infusion of the GLIDE 201/44 product could be administered at a dose level up to 3-5 fold the original dose.

Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)

An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Anti-minor Histocompatibility Complex (MiHA) Donor T-lymphocytes Expanded ex Vivo, in Patients With a Hematologic Malignancy, With Molecular or Clinical Relapse After Hematopoietic Stem Cell Transplantation From a Matched Donor

De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study end

No death or other toxic events directly related to GLIDE injection

Disease progression following GLIDE injection

Progression (if any) or induction of GvHD

Monitoring of GLIDE product persistence in host

Time to deaths without relapse/recurrence

It is time to any of the following: OS, RI, NRM, Time to relapse, Relapse free survival

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)	NCT03091933	Hematologic Can... Relapse Leukemi... Relapsed Adult ... Relapsed Adult ... Relapsed CLL Relapsed Non Ho... Relapsed Hodgki... Relapsed Myelod... Relapsed Multip...	GLIDE	18 Years - 65 Years	Ciusss de L'Est de l'Île de Montréal
Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)	NCT03091933	Hematologic Can... Relapse Leukemi... Relapsed Adult ... Relapsed Adult ... Relapsed CLL Relapsed Non Ho... Relapsed Hodgki... Relapsed Myelod... Relapsed Multip...	GLIDE	18 Years - 65 Years	Ciusss de L'Est de l'Île de Montréal

Spots Global Cancer Trial Database for relapsed hematopoietic malignancy