Clinical trial · Interventional
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.
NCT04764513CI-TRIAL-00057360unknownPhase 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 investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ex-vivo expanded γδ T cell infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with hematological malignancies after allo-HSCT
- description
- 1. Patients with negative minimal residual disease or stable disease: After inclusion, patients will receive or not receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. 2. Patients with positive minimal residual disease but not hematologic relapse: After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. 3. Patients with hematologic relapse: After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
- interventionNames
- Biological: Ex-vivo expanded γδ T cell infusion
Primary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]
- timeFrame
- Day 28 after completion of treatment
- description
- Safety of γδ T cell assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation; 2. Age criteria: 18-65 years; 3. Weight criteria: \> 40kg; 4. Organ function criteria: Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%, Pulmonary function: Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), Total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN; 5. Life expectancy of at least 4 months; 6. ECOG (Eastern Cooperative Oncology Group) score ≤ 2; 7. Patients able to understand and sign written informed consent. Exclusion Criteria: 1. GVHD (graft versus host disease) ≥ grade Ⅱ; 2. Thrombotic microangiopathy; 3. Posttransplant lymphoproliferative disorders; 4. Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician); 5. Patients with chronic diseases that require treatment with immune agents or hormones; 6. Suffering from systemic autoimmune disease or immunodeficiency disease; 7. Systemic use of steroids; 8. Allergic constitution; 9. Hemorrhagic disease or coagulation disorders; 10. Patients participating in other clinical trials within 30 days prior to enrollment; 11. Patients receiving radiotherapy within 4 weeks prior to enrollment; 12. Pregnant or breastfeeding women; 13. According to the researcher's judgment, the patient has other unsuitable conditions.
References
Publications (0)
Data not yet available
No reference posted for this study.