About this trial
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent
Failed to standard chemotherapy regimens;
Relapse after complete remission, high-risk and / or refractory patients ;
Relapse after hematopoietic stem cell transplantation;
Disqualifiers
Previous history of other malignancy;
Presence of uncontrolled active infection;
Evidence of disorder that need the treatment by glucocorticoids;
Active or chronic GVHD
Trial design
Single group
Treatments tested in this trial
CD19 and CD22 targeted prime CAR-T cells
Biological/VaccineA single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
Treatment groups
Trial outcomes
Primary outcomes
Adverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL
The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
Secondary outcomes
Rate of prime CAR-T cells in bone marrow
Determine the rate of prime CAR-T cells in bone marrow by flow cytometry
Rate of prime CAR-T cells in peripheral blood
Determine the rate of prime CAR-T cells in peripheral blood by flow cytometry
Quantity of prime CAR copies in bone marrow
Determine the quantity of prime CAR copies in bone marrow by qPCR
Quantity of prime CAR copies in peripheral blood
Determine the quantity of prime CAR copies in peripheral blood by qPCR
Sponsors and contacts
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