NCT05800210

Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 6 Months – 39 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Juvenile Myelomonocytic Leukemia
• Myelodysplastic Syndromes
• Chronic Myeloid Leukemia
• Lymphoma, Non-Hodgkin
• Lymphoma, Hodgkin

Interventions

Type	Name	Description
DEVICE	Miltenyi CliniMACS Prodigy ® system	Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.

Timeline

• Start date: 2024-05-03
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2023-04-05
• Last updated: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study