NCT05507827

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)

Study 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.

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Interventions

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

Study Locations

FacilityCityStateCountry
Stanford Cancer CenterPalo AltoCaliforniaUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026