Clinical trial · Interventional
Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors
Allogeneic γ9δ2 T Cells for the Treatment of Recurrent Hematologic Tumors After Allogeneic Hematopoietic Stem Cell Transplantation
NCT05755854CI-TRIAL-00069844unknownPhase 1ClinicalTrials.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 is an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 T cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation.
Conditions
Conditions (1)
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 Diseases | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic γ9δ2 T Cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Zoredronic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation
- description
- A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, zoredronic acid depending on the patient's status, followed by investigational therapy, allogeneic γ9δ2 T Cells
- interventionNames
- Biological: allogeneic γ9δ2 T Cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Drug: Zoredronic acid
Primary outcomes (4)
- measure
- Incidence of Adverse Events (AEs)
- timeFrame
- 12 months
- description
- AE is defined as any adverse medical event from the date of leukapheresis to 12 months after allogeneic γ9δ2 T cells infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 12-65 (inclusive); 2. Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation; 3. Basically normal liver and kidney function (as demonstrated by the following laboratory tests prior to initial γ9δ2 T cell therapy) * Alanine transaminase/aspartate transaminase \< 2.5×ULN; * serum creatinine \< 1.5×ULN; * total bilirubin level \< 1.5×ULN; 4. No obvious hereditary disease; 5. Normal cardiac function, cardiac ejection index above 55%; 6. Women of reproductive age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative, and use contraception during the clinical trial period and within 3 months after the last cell transfusion; 7. Sign informed consent. Exclusion Criteria: 1. Patients with simple extramedullary recurrence; 2. Pregnant and lactating women; 3. Organ failure; * Heart: Ⅲ level and Ⅳ level; * Liver: reach the grade C Child - Turcotte liver function; * Kidney, renal failure and uremia period; * Lung: symptoms of severe respiratory failure; * Brain: consciousness disorder. 4. Patients with a history of solid organ transplantation; 5. Uncontrollable infectious diseases or other serious diseases, including but not limited to infections (such as HIV positive), congestive heart failure, unstable angina, arrhythmia, psychosis, or restricted social circumstances or those that the attending physician considers to pose unpredictable risks; 6. Patients with systemic autoimmune diseases or primary immunodeficiency; 7. Patients with allergic constitution; 8. Use of systemic steroid drugs; 9. Chronic diseases requiring the use of immunological agents or hormone herapy; 10. Prior treatment with any other immune cells; 11. Participated in similar clinical trials within 30 days; 12. Received radiation therapy within 4 weeks from the time of enrollment; 13. Researchers don't think clinical trials are appropriate for other reasons.
References
Publications (0)
Data not yet available
No reference posted for this study.