About this trial
A Clinical Study to Explore the Safety, Efficacy and Cellular Metabolic Kinetics of CT1195E CAR-T Cells Injection in Patients with Relapsed/Refractory B-Cell Neoplasms
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
R/R B-NHL Inclusion Criteria:
Cohort A1: Patients who have previously received standard systemic therapy, including regimens containing anti-CD20 drugs (except CD20 negative) and anthracyclines;
Cohort A2: Prior standard systemic therapy, including an anti-CD20 agent (except CD20 negative) , anthracycline or bendamustine-containing regimen, and a BTK inhibitor;
Hematology: ① Platelet (PLT) ≥ 75 × 109/L (study participants with bone marrow or peripheral blood involvement: PLT ≥ 50 × 109/L), ② Hemoglobin (Hb) ≥ 80 g/L (study participants with bone marrow or peripheral blood involvement: Hb ≥ 60 g/L);
Disqualifiers
R/R B-NHL Exclusion Criteria:
Pregnant or lactating females;
Study participants with a history of neurological disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disorders or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;
Presence of HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);
Trial design
Single group
Treatments tested in this trial
CAR T cells chimeric antigenreceptor cells
DrugCT1195E cells infusion
Treatment groups
Trial outcomes
Primary outcomes
To assess the severity and incidence of DLTs, treatment-related adverse events (TRAE), and adverse events of special interest (AESI) after CT1195E infusion
MTD or dose range
To explore the maximum tolerated dose (MTD) or dose range of CT1195E
Secondary outcomes
Overall Response Rate (ORR)
Complete response rate (CRR)
Minimal Residual Disease Negative (MRD-) Proportion (R/R B-ALL)
Duration of response (DOR)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: