Clinical trial · Interventional
Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)
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
NCT03091933CI-TRIAL-00030699GLIDEunknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Relapsed Adult ALL | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed Adult AML | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Relapsed CLL | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed Hodgkin's Lymphoma | Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Relapsed Myelodysplastic Syndromes | Myelodysplastic Syndrome | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GLIDE | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GLIDE
- description
- GLIDE single infusion at a target dose of 4x107 viable T-cells/m2
- interventionNames
- Biological: GLIDE
Primary outcomes (1)
- measure
- Non-hematologic toxicity related to GLIDE post injection
- timeFrame
- 6 months
- description
- No death or other toxic events directly related to GLIDE injection
Secondary outcomes (7)
- measure
- Response of hematologic malignancy (acute leukemia (ALL, AML, biphenotypic), CLL, HL, NHL, MM or MDS) post-injection
- timeFrame
- up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.