Recruiting
Phase 1
Phase 2

Anti-MiHA T Cell

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT03091933

Conditions

Hematologic Cancer

Relapse Leukemia

Relapsed Adult ALL

Relapsed Adult AML

Relapsed CLL

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

GLIDE

Study Details

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

Study ID

NCT03091933

Start date

Feb 6, 2017

Status verified date

Dec, 2017

Completion date

Mar 31, 2019

Anticipated

Primary completion date

Mar 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GLIDE

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

Interventions

GLIDE

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

Primary outcome measure

  • Non-hematologic toxicity related to GLIDE post injection [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jean-Guy Némorin, PhD

(514) 252-3400jgnemorin@centrec3i.com

Stéphanie Thiant, PhD

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

Locations

CIUSSS d l'Est-de-l'Île-de-Montréal

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Jean-Guy Némorin, PhD

514-252-3400jgnemorin@centrec3i.com

Stéphanie Thiant, PhD

214-252-3400sthiant.hmr@ssss.gouv.qc.ca

Principal Investigator:

Denis-Claude Roy, MD PhD

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Dec 6, 2017

Last verified

Dec, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2017-12-06.