drugset / Trial / NCT03862833

Zoledronic Acid in Combination With Interleukin-2 to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allotransplant

NCT03862833

Phase 1 Completed 30 enrolled Nantes University Hospital
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

EvaluationDrugModalityDoseRoute
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