Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
Summary
Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.
Timeline
- Start
- 2021-09-07
- Primary completion
- 2028-05
- Completion
- 2028-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | 50 mg/m2 | — |
| Subject | Melphalan | Small molecule | 100 mg/m2 | — |
| Subject | Purified regulatory T-cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Purified regulatory T-cells | Cell therapy | 3e+06 cells/kg | — |
| Subject | Thiotepa | Other / unclassified | 5 mg/kg | — |
| Subject | Thiotepa | Other / unclassified | 7.5 mg/kg | — |
| Subject | Thiotepa | Other / unclassified | 10 mg/kg | — |
| Background | CD34+ HSPC | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | 40 mg/kg | — |
| Background | Fludarabine | Small molecule | 160 mg/m2 | — |
| Background | Mycophenolate Mofetil | Small molecule | 1000 mg | — |
| Background | Plerixafor | Small molecule | 0.24 mg/kg | — |
| Background | Ruxolitinib | Small molecule | 5 mg | — |
| Background | Sirolimus | Small molecule | 5 ng/ml | — |
| Background | Sirolimus | Small molecule | 8 ng/ml | — |
| Background | Tacrolimus | Small molecule | 4 ng/ml | — |
| Background | Tacrolimus | Small molecule | 6 ng/ml | — |
| Background | filgrastim | Protein / enzyme biologic | 300 ug | — |
| Background | filgrastim | Protein / enzyme biologic | 480 ug | — |