This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL.
CD19-directed CAR-T cell therapy has shown promising results in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual-CARs enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
A single infusion of CD19 and CD22 CAR-T cells.
Given
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China
RECRUITINGSafety: Incidence of adverse events
To evaluate the possible adverse events that could occurred within the first month post SL19+22 infusion, including symptoms such as cytokine release syndrome and neurotoxicity.
Time frame: up to 28 days
Efficacy: Remission Rate
Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Time frame: Up to 3 months
Efficacy:duration of response (DOR)
Duration of response
Time frame: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of CD19 and CD22 CAR- T cells in the genomes of peripheral blood mononuclear cell (PBMC) by quantitative Real-time PCR (qPCR).
Time frame: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry
Time frame: First month post CAR-T cells infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.