Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Relapsed Adult ALL | Relapsed Adult AML | Relapse Leukemia | Relapsed Hodgkin's Lymphoma | Relapsed Myelodysplastic Syndromes | Hematologic Malignancy | Relapsed Non Hodgkin Lymphoma | Relapsed Multiple Myeloma | Relapsed CLL
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

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-B44:03, HLA-A01:01; HLA-A03:01; HLA-A11:01;HLA A24:02; HLA-A29:02; HLA-A32:01; HLA-B07:02; HLA-B08:01; HLA B13:02; HLA-B14:02; HLA-B15:01; HLA-B18:01; HLA-B27:05; HLA B35:01; HLA-B40:01; 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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