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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line
CIUSSS d l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
RECRUITINGNon-hematologic toxicity related to GLIDE post injection
No death or other toxic events directly related to GLIDE injection
Time frame: 6 months
Response of hematologic malignancy (acute leukemia (ALL, AML, biphenotypic), CLL, HL, NHL, MM or MDS) post-injection
Disease progression following GLIDE injection
Time frame: up to 12 months
Incidence and severity of acute and chronic graft versus host disease (GvHD)
Progression (if any) or induction of GvHD
Time frame: up to 12 months
Persistence of GLIDE in the host and homing to peripheral blood, bone marrow and other tissues
Monitoring of GLIDE product persistence in host
Time frame: up to 12 months
Non-Relapse mortality (NRM)
Time to deaths without relapse/recurrence
Time frame: up to 12 months
Relapse-incidence (RI)
Time to relapse
Time frame: up to 12 months
Overall survival (OS)
Time to death, irrespective of the cause
Time frame: up to 12 months
Progression-free survival (PFS)
It is time to any of the following: OS, RI, NRM, Time to relapse, Relapse free survival
Time frame: up to 12 months
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