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

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ClinicalTrials.gov Identifier: NCT03091933
Recruitment Status : Unknown
Verified December 2017 by Ciusss de L'Est de l'Île de Montréal.
Recruitment status was:  Recruiting
First Posted : March 27, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ciusss de L'Est de l'Île de Montréal

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hematologic Cancer Relapse Leukemia Relapsed Adult ALL Relapsed Adult AML Relapsed CLL Relapsed Non Hodgkin Lymphoma Relapsed Hodgkin's Lymphoma Relapsed Myelodysplastic Syndromes Relapsed Multiple Myeloma Biological: GLIDE Phase 1 Phase 2

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: exploratory, open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: GLIDE
GLIDE single infusion at a target dose of 4x107 viable T-cells/m2
 Biological: GLIDE
Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line


Outcome Measures
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Primary Outcome Measures :
  1. Non-hematologic toxicity related to GLIDE post injection [ Time Frame: 6 months ]
    No death or other toxic events directly related to GLIDE injection


Secondary Outcome Measures :
  1. Response of hematologic malignancy (acute leukemia (ALL, AML, biphenotypic), CLL, HL, NHL, MM or MDS) post-injection [ Time Frame: up to 12 months ]
    Disease progression following GLIDE injection

  2. Incidence and severity of acute and chronic graft versus host disease (GvHD) [ Time Frame: up to 12 months ]
    Progression (if any) or induction of GvHD

  3. Persistence of GLIDE in the host and homing to peripheral blood, bone marrow and other tissues [ Time Frame: up to 12 months ]
    Monitoring of GLIDE product persistence in host

  4. Non-Relapse mortality (NRM) [ Time Frame: up to 12 months ]
    Time to deaths without relapse/recurrence

  5. Relapse-incidence (RI) [ Time Frame: up to 12 months ]
    Time to relapse

  6. Overall survival (OS) [ Time Frame: up to 12 months ]
    Time to death, irrespective of the cause

  7. Progression-free survival (PFS) [ Time Frame: up to 12 months ]
    It is time to any of the following: OS, RI, NRM, Time to relapse, Relapse free survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091933


Contacts
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Contact: Jean-Guy Némorin, PhD (514) 252-3400 ext 6247 jgnemorin@centrec3i.com
Contact: Stéphanie Thiant, PhD (514) 252-3400 ext 4681 sthiant.hmr@ssss.gouv.qc.ca

Locations
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Canada, Quebec
CIUSSS d l'Est-de-l'Île-de-Montréal Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Jean-Guy Némorin, PhD    514-252-3400 ext 6247    jgnemorin@centrec3i.com   
Contact: Stéphanie Thiant, PhD    214-252-3400 ext 4681    sthiant.hmr@ssss.gouv.qc.ca   
Principal Investigator: Denis-Claude Roy, MD PhD         
Sub-Investigator: Jean-Sébastien Delisle, MD PhD         
Sub-Investigator: Silvy Lachance, MD         
Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
Investigators
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Principal Investigator: Denis-Claude Roy, MD PhD CIUSSS d l'Est-de-l'Île-de-Montréal
Principal Investigator: Jean-Sébastien Delisle, MD PhD CIUSSS d l'Est-de-l'Île-de-Montréal
Principal Investigator: Silvy Lachance, MD CIUSSS d l'Est-de-l'Île-de-Montréal
More Information
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Responsible Party: Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT03091933    
Other Study ID Numbers: CR-MIHA-001
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study end

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ciusss de L'Est de l'Île de Montréal:
allogeneic hematopoietic stem cell transplantation
relapsed hematopoietic malignancy
HLA matched donor
minor histocompatibilty antigen (MiHA)
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms
Hematologic Neoplasms
Myelodysplastic Syndromes
Recurrence
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
 Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Disease Attributes
Pathologic Processes
Neoplasms by Site