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Clinical Trial Summary

To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T for the treatment of measurable residual disaese (MRD)-positive B cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells.


Clinical Trial Description

Participants with MRD-positive B cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws. Participants receive chemotherapy prior to the infusion of CD19/CD22 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19/CD22 CAR+ T cells. Study procedures may be performed while hospitalized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03919526
Study type Interventional
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact
Status Completed
Phase Phase 1
Start date August 11, 2019
Completion date November 1, 2023

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