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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
30mg/m2/d
300mg/m2/d
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
Time frame: 28 days post infusion
MRD clearance
MRD clearance
Time frame: 3 months post infusion
Content of CD19 positive B-cells in peripheral blood
Content of CD19 positive B-cells in peripheral blood
Time frame: 3 months post infusion
Content of CAR-T related cytokines positive T cells in circulation
Content of CAR-T related cytokines positive T cells in circulation
Time frame: 3 months post infusion
Total response rate (ORR) after administration
Total response rate (ORR) after administration including complete response(CR) and partial response(PR)
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
Duration of remission (DOR) after administration
Time frame: 2 years post infusion
Overall Survival (OS)after administration
Overall Survival (OS)after administration
Time frame: 2 years post infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.