NCT04099966

AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion - NYMC 588

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mitchell Cairo · Academic / Other
• Sex: All
• Age: 1 Day – 30 Years
• Healthy volunteers: Not accepted

Summary

Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.

Detailed description

Patients wiith selected malignant or non-malignant conditions meeting eligibility criteria will be enrolled on this study. Patients will receive one of either full intensity, reduced intensity, or reduced toxicity conditioning appropriate based on disease, disease status, organ function and performance status and will undergo α/β T-cell and CD 19+ B cell depleted alloSCT. Patients will be following for engraftment, chimerism, immune reconstitution, GVHD and QOL.

Conditions

• Acute Leukemia
• Severe Aplastic Anemia
• Non-hodgkin Lymphoma
• Hodgkin Lymphoma
• Kostmann
• Diamond Blackfan Anemia
• Amegakaryocytic Thrombocytopenia
• Sickle Cell Disease
• Beta-Thalassemia

Interventions

Type	Name	Description
DRUG	alpha beta depletion	donor cells will be collected and subsequently undergo α/β CD3+/CD19+ cell depletion.

Timeline

• Start date: 2021-04-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2019-09-23
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study