NCT03145545

Expanded Access Protocol Using Alpha/Beta T and CD19+ Depleted PBSC

Expanded Access Protocol Using TCR Alpha/Beta T Cell/CD19+ Depleted Donor Peripheral Stem Cells

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: —

Summary

The primary objective of this protocol is to expand access for patients who lack a fully HLA (Human leukocyte antigen) matched sibling donor, and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-threatening disease for which HSCT is indicated. These patients are not eligible for other Children's Hospital of Philadelphia Institutional Review Board (IRB) approved protocols that utilize CliniMACs technology for T depletion.

Detailed description

Only 25-30% of patients who may benefit from HSCT have a matched related donor. An unrelated cord blood may not be available due to size or matching criteria, or if a reduced intensity regiment is recommended. The risk of severe graft vs. host disease (GVHD) and other complications is higher with unrelated donors, or partially matched related donors. At the Children's Hospital of Philadelphia (CHOP) there is extensive experience using mismatched unrelated donors or partially matched related donors with complete or partial T depletion to reduce the risk of severe GVHD.

Conditions

• Leukemia
• Bone Marrow Failure Syndrome
• Immunodeficiencies

Interventions

Type	Name	Description
DEVICE	Apha/beta T and CD19+ cell depletion using CliniMACS device	Stem cells will be processed using the CliniMACS device for alpha/beta and CD19+ T cell depletion. Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory standard operating procedures (SOPs) and using aseptic technique.

Timeline

• First posted: 2017-05-09
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States