A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia.
Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements
18-75 years old;
Histologically or cytologically confirmed B-ALL;
Previously received at least 2 lines of systemic therapy;
Pregnant or lactating women;
Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis Cvirus infection (HCV antibody and HCV-DNA positive);
Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade1, except alopecia and other events that are judged tolerable by the investigator;
Single group
Chimeric Antigen Receptor T Cells (CAR-T)
Drugchimeric antigen receptor T cells
MTD and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT119X infusion
Adverse Events (AE) after CT119X infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Overall response rate （ORR）
The proportion of patients with complete remission（CR）/partial response (PR) after CT119X infusion.
Complete response rate (CRR)
The proportion of patients with complete response(CR) after CT119X infusion
Duration of remission(DOR)
Participants achieving CR/PR will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first.
Time to response (TTR)
The time from cell infusion to the first assessment of CR or PR
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