NCT05507827

Myeloablative Conditioning Orca-T & Allogeneic Donor-Derived CD19/CD22-CAR TCells in B-Cell ALL

Phase I Trial Evaluating the Safety of Myeloablative Conditioning, Orca-T, and Allogeneic, Donor-Derived CD19/CD22-CAR (Chimeric Antigen Receptor) T Cells in Adults With B-Cell Acute Lymphoblastic Leukemia (ALL)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety of administering allogenic, donor-derived CD19/CD22-CAR T cells that meet established release specifications in adults with B-cell ALL following a myeloablative conditioning regimen and Orca-T to determine if this will augment graft versus leukemia without increasing acute GVHD or graft failure.

Conditions

• Lymphoid Leukemia

Interventions

Type	Name	Description
DRUG	Allogeneic donor-derived T-cells transduced with bivalent lentiviral vector (CD19/CD22-BBz) chimeric antigen receptor (CAR)	CD19/C22CAR T cells will be administered at a dose of CAR+ cells/kg body weight via IV administration
DRUG	Treg CD34+HSPC (Orca-T)	Purified donor-derived regulatory T-cell (Treg) plus CD34 + hematopoietic progenitor cells

Timeline

• Start date: 2022-08-18
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-08-19
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study