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RECRUITING
NCT04249830
NA

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

Sponsor: Alice Bertaina

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

1 Month - 60 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2020-02-01

Completion Date

2030-12

Last Updated

2025-05-29

Healthy Volunteers

No

Interventions

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).

Locations (1)

Lucile Packard Children's Hospital

Palo Alto, California, United States