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

NCT03091933 | Unknown Phase 1 DMC

• 1 other identifier: CR-MIHA-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

allogeneic hematopoietic stem cell transplantation; relapsed hematopoietic malignancy; HLA matched donor; minor histocompatibilty antigen (MiHA)

Outcome Measures

Primary Outcomes (1)

• Non-hematologic toxicity related to GLIDE post injection

  No death or other toxic events directly related to GLIDE injection

  6 months

Secondary Outcomes (7)

• Response of hematologic malignancy (acute leukemia (ALL, AML, biphenotypic), CLL, HL, NHL, MM or MDS) post-injection

  up to 12 months

• Incidence and severity of acute and chronic graft versus host disease (GvHD)

  up to 12 months

• Persistence of GLIDE in the host and homing to peripheral blood, bone marrow and other tissues

  up to 12 months

• Non-Relapse mortality (NRM)

  up to 12 months

• Relapse-incidence (RI)

  up to 12 months

Study Arms (1)

GLIDE

EXPERIMENTAL

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

Biological: GLIDE

Interventions

GLIDE BIOLOGICAL

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

GLIDE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS d l'Est-de-l'Île-de-Montréal

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin; Hodgkin Disease; Myelodysplastic Syndromes; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Lymphoma; Bone Marrow Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Guy Némorin, PhD

CONTACT

(514) 252-3400; jgnemorin@centrec3i.com

Stéphanie Thiant, PhD

CONTACT

(514) 252-3400; sthiant.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: exploratory, open-label

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: February 6, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2019
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

CA (1)