NCT04249830

Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults

Allogeneic Hematopoietic Stem Cell Transplantation From an HLA-partially Matched Related or Unrelated Donor After TCR αβ+T Cells/CD19+ B Cell Depletion in Children and Young Adults Affected by Malignant or Non-Malignant Hematological Disorders

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Alice Bertaina · Academic / Other
• Sex: All
• Age: 1 Month – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.

Conditions

• Hematologic Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Stem Cell Transplant	The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.
DEVICE	CliniMACS TCR α/β Reagent Kit and CliniMACS CD19	The CliniMACS™system can be used to selectively enrich or reduce specific cell populations based on the magnetic cell selection (MACS) technology developed by Miltenyi Biotec. Cell mixtures can be separated in a magnetic field using one or more immunomagnetic- labeled antibodies specific for the cell types of interest (e.g.TCR αβ+ T cells and CD19+ B cells from HPC(A) products).

Timeline

• Start date: 2020-02-01
• Primary completion: 2028-12-01
• Completion: 2030-12-01
• First posted: 2020-01-31
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study