A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1194C CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell NonHodgkin Lymphoma.
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1194C cells in patients with B-NHL. It is planned to enroll 3-27 participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
CT1194C cells infusion
China Institute of Hematology and Blood Diseases Hospital
Tianjin, China
Adverse Events (AE) after CT1194C infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Time frame: 12 months after CT1194C infusion
MTD and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT1194C infusion
Time frame: Up to 28 days after CAR-T cells infusion
Overall response rate (ORR)
The proportion of patients with complete remission(CR)/partial response (PR) after CT1194C 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 CT1194C infusion
Time frame: 12 months after CT1194C 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 CT1194C infusion
Time to response (TTR)
The time from cell infusion to the first assessment of CR or PR
Time frame: 12 months after CT1194C infusion
Time to complete response (TTCR)
The time from cell infusion to the first assessment of CR
Time frame: 12 months after CT1194C 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 CT1194C cells to the first assessment of disease progression or death.
Time frame: 12 months after CT1194C 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 CT1194C infusion]