drugset / Trial / NCT07052370
TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I, prospective clinical trial studying the safety and feasibility of providing early memory T-cell DLI. The primary objective is: \- To assess the safety and feasibility of early CD45RA-depleted DLI administration. The secondary objectives are * To assess the safety and feasibility of the addition of blinatumomab in the early post-transplant period in patients with CD19+ malignancy. * To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study.
Timeline
- Start
- 2025-09-25
- Primary completion
- 2028-12
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blinatumomab | Monoclonal antibody | — | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 5 mg/kg | — |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |
| Background | Fludarabine | Small molecule | 150 mg/m2 | — |
| Background | Melphalan | Small molecule | 70 mg/m2 | — |
| Background | Thiotepa | Other / unclassified | 10 mg/kg | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |