drugset / Trial / NCT03862833
Zoledronic Acid in Combination With Interleukin-2 to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allotransplant
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Patients receiving haplo-SCT are at high-risk of relapse. Vγ9Vδ2 T cells exhibit is a well-known population able to exert cytotoxicity toward a large range of tumor in vitro or in vivo. Activating and expanding Vγ9Vδ2 T cells early after haplo-SCT by using a combination of Zoledronic acid and low-dose interleukine (IL) -2 may be of benefit for patients by reducing incidence of relapse. The optimal dose of IL-2 to use remains to be determined. This will be a Phase 1 3+3 escalation study. Three to 15 patients are planned. It will be proposed to Patients who refuse to participate to have samples collected until day +70 to study immune and gamma/delta T cells reconstitutions after haplo-transplant.
Timeline
- Start
- 2019-05-07
- Primary completion
- 2023-08-29
- Completion
- 2023-08-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zoledronic acid | Other / unclassified | 4 mg | Intravenous |
| Subject | aldesleukin | Protein / enzyme biologic | 2 iu | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 4 iu | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 6 iu | Subcutaneous |