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

Sponsored by Ciusss de L'Est de l'Île de Montréal

About this trial

Last updated 9 years ago

Study ID

CR-MIHA-001

Status

Unknown

Type

Interventional

Phase

Phase 1

Placebo

Accepting

18 to 65 Years

All Sexes

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* Prior allogeneic HLA-matched stem cell transplantation

* Any of the following hematologic malignancies:

* Acute myeloid leukemia (AML)

* Acute lymphoblastic leukemia (ALL)

* Biphenotypic leukemia

* Chronic lymphoblastic leukemia (CLL)

* Hodgkin Lymphoma

* Non-Hodgkin Lymphoma (NHL)

* Multiple Myeloma (MM)

* Myelodysplastic syndrome (MDS)

* Presence of HLA2:01 and / or HLA44:02 and / or HLA-B*44:03, HLA-A*01:01; HLA-A*03:01; HLA-A*11:01;HLA A*24:02; HLA-A*29:02; HLA-A*32:01; HLA-B*07:02; HLA-B*08:01; HLA B*13:02; HLA-B*14:02; HLA-B*15:01; HLA-B*18:01; HLA-B*27:05; HLA B*35:01; HLA-B*40:01; or HLA-B*57:01

* At least 6 months after allogeneic hematopoietic stem cell transplantation

* Presence of detectable malignant disease post-transplantation in the form of molecular, cytogenetic or hematologic relapse of the malignant disorder.

* Eligible to receive cytoreductive chemotherapy

* Original stem cell donor available for leukocyte donation.

* ECOG performance status ≤2.

* Ability to provide written consent.

* Accessible for treatment and follow up.

* Presence of a targetable MiHA based on exome sequencing of the patient and donor

Exclusion Criteria

* Active acute GVHD > grade I

* Prior grade III-IV acute GVHD within the last year

* Uncontrolled chronic GVHD

* Prior administration of donor lymphocyte infusion (DLI)

* Use of T-cell depleting antibodies in the previous 30 days

* Treatment with immune suppressors (oral or parenteral steroids corresponding to a dose of prednisone greater than 7.5 mg/day, calcineurine inhibitors, rapamycin, mycophenolate mofetil, etc) during the last 30 days.

* Uncontrolled active infection

* Uncontrolled central nervous system involvement by leukemia cells (blasts).

* AST or ALT > 2.5 x ULN (CTCAE grade 2)

* Bilirubin > 1.5 x ULN (CTCAE grade 2)

* Creatinine clearance < 50 mL/min

* Positive test for human immunodeficiency virus (HIV)

* Positive pregnancy test (women of childbearing age only)

* Lactating women: the safety of this therapy on breast milk is not known.

* Estimated probability of surviving less than 3 months

* Known allergy to any of the components of GLIDE (e.g., dimethyl sulfoxide)

* Intercurrent illness or medical condition precluding safe administration of the planned protocol treatment or required follow-up.