This study is a single arm, open label, dose exploring clinical study to evaluate the safety, efficacy, metabolic kinetics and pharmacodynamics of CT1182 cells in patients with relapsed / refractory B-cell non Hodgkin lymphoma (r/r B-NHL).
voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; Willing to follow and be able to complete all research procedures;
age 18-75 years (inclusive);
r/r B-NHL diagnosed by histology or cytology includes large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (hgbl) according to the WHO classification of lymphoproliferation and tumor (5th Edition, 2022); Grade 3B follicular lymphoma (fl3b); Follicular lymphoma (FL) or marginal zone lymphoma (MZL) - transformed DLBCL; Primary mediastinal large B-cell lymphoma (pmbcl); Burkitt lymphoma (BL); Mantle cell lymphoma (MCL).
have received standardized systemic treatment in the past, including anti-CD20 drugs (except CD20 negative) and anthracyclines;
pregnant or lactating women;
research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, mental disease or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;
HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA higher than the detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);
according to the investigator's judgment, there is currently any uncontrollable active infection, including but not limited to active tuberculosis;
Single group
CT1182 injection
Biological/VaccineCT1182 injection is an in vivo car-t product (CT1182) independently developed by carsgen company based on carvivo ™ platform, which simultaneously targets CD19 and CD20. Carvivo ™ platform uses redirected lentiviral vector technology to directly target and transduce T cells and generate functional car-t cells in vivo after intravenous infusion of lentivirus to achieve specific targeted killing of tumor cells. The CT1182 product adopts an optimized mutant engineered vesicular stomatitis virus (VSV) envelope, which makes the lentivirus lose its pan tropism. At the same time, it loads redirected CD3 targeting molecules on the virus surface to achieve specific transduction of T cells.
Frequency, type and severity of AES
To evaluate the severity and incidence of treatment-related adverse events (TARE) and adverse events of special concern (AESI) after CT1182 infusion
The number and severity of dose-limiting toxicity (DLT)events
DLT was collected to explore the maximum tolerated dose (MTD) and / or dose range of CT1182
Investigator assessed objective response rate (ORR)
Investigator assessed complete response rate (CRR)
Investigator assessed duration of remission (DOR)
Investigator assessed time to remission (TTR)
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
CARsgen Life Sciences Co.,Ltd.
Collaborator
