A Phase 1 interventional study of CAR T cells in B-Cell Non-Hodgkin Lymphoma, sponsored by Kai Hu. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Kai Hu · Phase 1, Interventional, and Treatment
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma.
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with B-NHL. It is planned to enroll 6-24 participants.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Kai Hu is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CT1190B cells infusion
Drug: CAR T cells
chimeric antigen receptor T cells
Adverse Events (AE) after CT1190B infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Time frame: 12 months after CT1190B infusion
MTD and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT0991 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 CT1190B 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 CT1190B infusion
Time frame: 12 months after CT1190B 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 CT1190B infusion
Time to response (TTR)
The time from cell infusion to the first assessment of CR or PR
Time frame: 12 months after CT1190B infusion
Time to complete response (TTCR)
The time from cell infusion to the first assessment of CR
Time frame: 12 months after CT1190B infusion
Progression-free survival (PFS)
The time from the infusion of CT1190B cells to the first assessment of disease progression or death.
Time frame: 12 months after CT1190B 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 CT1190B infusion
Plan to share: No
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