Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)
NCT ID: NCT03091933
Last Updated: 2017-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2017-02-06
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GLIDE
GLIDE single infusion at a target dose of 4x107 viable T-cells/m2
GLIDE
Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line
Interventions
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GLIDE
Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Ciusss de L'Est de l'Île de Montréal
OTHER
Responsible Party
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Principal Investigators
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Denis-Claude Roy, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CIUSSS d l'Est-de-l'Île-de-Montréal
Jean-Sébastien Delisle, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CIUSSS d l'Est-de-l'Île-de-Montréal
Silvy Lachance, MD
Role: PRINCIPAL_INVESTIGATOR
CIUSSS d l'Est-de-l'Île-de-Montréal
Locations
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CIUSSS d l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Jean-Guy Némorin, PhD
Role: primary
Stéphanie Thiant, PhD
Role: backup
Other Identifiers
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CR-MIHA-001
Identifier Type: -
Identifier Source: org_study_id