NCT05735717

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

Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematologic Malignancy
• Acute Leukemia
• Remission
• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• AML
• TP53
• Intrachromosomal Amplification of Chromosome 21
• Cytogenetic Abnormality
• CNS Leukemia
• Minimal Residual Disease
• Myelodysplasia
• Juvenile Myelomonocytic Leukemia
• Somatic Mutation
• PTPN11 Gene Mutation
• N-RAS Gene Amplification
• Neurofibromatosis 1
• NF1 Mutation
• CBL Gene Mutation
• Monosomy 7
• Chromosome Abnormality
• Fetal Hemoglobin
• Lymphoblastic Lymphoma
• High Grade Non-Hodgkin's Lymphoma, Adult

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
DRUG	Busulfan	Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5
DRUG	Melphalan	Melphalan 50 mg/m2 IV on days -4 to -2
DRUG	Rituximab	200 mg/m2 intravenous given once on day-1
DRUG	Levetiracetam	As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.
BIOLOGICAL	Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells	Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
DRUG	Thymoglobulin	rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.
DRUG	Cyclophosphamide	Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2

Timeline

• Start date: 2023-05-11
• Primary completion: 2027-11-30
• Completion: 2030-11-30
• First posted: 2023-02-21
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study