In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.
After clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, CAR-T technique can be used for related treatment, and the long-term therapeutic effect can be observed. In this trial, 50 children were publicly enrolled and treated with CAR-T. Patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
CD19+22 CAR-T infusion for pediatric 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
Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis
Time frame: 28 days
CAR-T Cell expansion level
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