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's Lymphoma.
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 and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.
18-75 years old;
Cohort A1: Previously received at least 2 lines of systemic therapy, including anti-CD20 drugs (unless the investigator had determined that the tumor is/is CD20 negative) and anthracycline containing regimens, anti-CD20 drugs maintenance alone will not be counted as 1 line of treatment; for participants with transformed FL (FLBL), any treatment administered prior to transformation will not be counted as a prior line.
Cohort A2: at least 2 prior lines of systemic therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 drugs ( unless the investigator had determined that the tumor is/is CD20 negative) and a BTK inhibitor; and CD20 monoclonal antibody alone will not be count as 1 line of treatment;
Pregnant or lactating women;
Has HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above the detection limit), or active hepatitis C virus 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) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;
Single group
CAR T cells
Drugchimeric antigen receptor T cells
MTD and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT1190b/CT1190b-p infusion
chimeric antigen receptor T cells
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 CT1190B/CT1190B-P infusion.
Complete response rate (CRR)
The proportion of patients with complete response(CR) after CT1190B/CT1190B-P 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.
Progression-free survival (PFS)
The time from the infusion of CT1190B cells to the first assessment of disease progression or death.
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