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
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B-ALL to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
920th Hospital of Joint Logistics Support Force
Kunming, Yunnan, China
RECRUITINGAdverse 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)
Time frame: 2 years
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
Time frame: 6 months
Rate of prime CAR-T cells in bone marrow
Determine the rate of prime CAR-T cells in bone marrow by flow cytometry
Time frame: 2 years
Rate of prime CAR-T cells in peripheral blood
Determine the rate of prime CAR-T cells in peripheral blood by flow cytometry
Time frame: 2 years
Quantity of prime CAR copies in bone marrow
Determine the quantity of prime CAR copies in bone marrow by qPCR
Time frame: 2 years
Quantity of prime CAR copies in peripheral blood
Determine the quantity of prime CAR copies in peripheral blood by qPCR
Time frame: 2 years
Rate of CD19 and CD22 positive cells in Bone marrow
Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry
Time frame: 1 years
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Levels of IL-6 in Serum
Serological determination of IL-6
Time frame: 3 months
Levels of IL-10 in Serum
Serological determination of IL-10
Time frame: 3 months
Levels of TNF-α in Serum
Serological determination of TNF-α
Time frame: 3 months
Levels of CRP in Serum
Serological determination of CRP
Time frame: 3 months
Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL
DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)
Time frame: 2 years
Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B-ALL
PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Time frame: 2 years
Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL
OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored)
Time frame: 2 years