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.
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT119X (including CT1190-P and CT1192)cells in patients with B-ALL. It is planned to enroll 6-36participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
chimeric antigen receptor T cells
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China
MTD and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT119X infusion
Time frame: Up to 28 days after CAR-T cells infusion
Adverse Events (AE) after CT119X infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Time frame: 12 months after CT119X infusion
Overall response rate (ORR)
The proportion of patients with complete remission(CR)/partial response (PR) after CT119X infusion.
Time frame: Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion
Complete response rate (CRR)
The proportion of patients with complete response(CR) after CT119X infusion
Time frame: 12 months 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 frame: 12 months after CT119X infusion
Time to response (TTR)
The time from cell infusion to the first assessment of CR or PR
Time frame: 12 months after CT119X infusion
Time to complete response (TTCR)
The time from cell infusion to the first assessment of CR
Time frame: 12 months after CT119X infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Progression-free survival (PFS)
The time from the infusion of CT119X cells to the first assessment of disease progression or death.
Time frame: 12 months after CT119X infusion
Overall survival (OS)
defined as the time from the date of receiving the infusion to the date of death from any cause
Time frame: 12 months after CT119X infusion