This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.
This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
CD19 CAR-T infusion for patients with CD19 positive tumor cells
CD22 CAR-T infusion for patients with CD22 positive tumor cells
CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
No.2 Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGNumber of Participants with Severe/Adverse Events as a Measure of Safety
Number of Participants with Severe/Adverse Events as a Measure of Safety
Time frame: 28 days
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Time frame: 24 months
Objective response rate of complete remission and partial remission
Objective response rate of complete remission and partial remission
Time frame: 24 months
Overall survival time
Overall survival time
Time frame: 24 months
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25mg/㎡ for D-4、D-3 and D-2
500mg/㎡ for D-3 and D-2