drugset
drugset / Trial / NCT05735717

MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

NCT05735717 ↗

Phase 2 Recruiting 70 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.

Timeline

Start
2023-05-11
Primary completion
2027-11-30
Completion
2030-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells Unknown — —
Background Busulfan Small molecule 82.1 unknown Intravenous
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background Levetiracetam Other / unclassified — —
Background Melphalan Small molecule 50 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 200 mg/m2 Intravenous
Background Thymoglobulin Protein / enzyme biologic — —

Indications

CBL-related disorder acute lymphoblastic leukemia acute myeloid leukemia central nervous system leukemia chromosome 21 disorder chromosome 7 disorder juvenile myelomonocytic leukemia lymphoblastic lymphoma myelodysplastic syndrome neurofibromatosis type 1 due to NF1 mutation or intragenic deletion