A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma

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;

there is known or suspected long-term active infection of EBV and a known history of HLH;

have received autologous stem cell transplantation or autologous cell therapy within 3 months before signing the informed consent; Previously received allogeneic stem cell transplantation or allogeneic donor derived cell adoptive therapy;

have received previous treatment targeting CD19 (unless the CD19 or CD20 target test is still positive);

previously received pseudotyped viral vector related treatment with vesicular stomatitis virus glycoprotein (VSVG) as envelope protein (including but not limited to VSVG pseudotyped lentivirus, adenovirus or other viral vector mediated gene therapy, oncolytic virus therapy, etc.);

CT1182 has received anti-tumor treatment within 14 days before infusion or within 5 half lives (whichever is shorter), including but not limited to cytotoxic drugs, targeted therapy, radiotherapy, epigenetic therapy or experimental drug treatment, or has used invasive experimental medical devices. ;

receive systemic glucocorticoids equivalent to \>15 mg/ day prednisone within 7 days before signing the informed consent, except for topical glucocorticoids or physiological replacement therapy;

have been vaccinated within 4 weeks before signing the informed consent, or it is expected that live attenuated vaccine, inactivated vaccine or RNA vaccine will be vaccinated during the trial or within 12 months after ct1182 infusion;

known allergy to ct1182 or any formulation component, allergy or intolerance to tocilizumab, or previous history of other serious allergies such as anaphylactic shock;

study participants with any of the following cardiac diseases:

1. The New York Heart Association (NYHA) cardiac function classification was grade III or IV heart failure;

2. Myocardial infarction, unstable angina pectoris, or coronary artery bypass grafting or coronary stent implantation occurred within 6 months before screening;

3. There is a history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;

4. ;

5. Other heart diseases that the investigator believes may endanger the safety of study participants due to participation in this study;

suffering from serious lung disease, and participating in this study may endanger the safety of participants according to the judgment of the investigator;

the second primary malignant tumor requiring treatment or incomplete remission in the past 3 years, except the following successfully treated tumors with low malignancy such as non metastatic basal cell carcinoma or squamous cell skin carcinoma, non metastatic prostate cancer, breast cancer or cervical cancer in situ, non muscle invasive bladder cancer or thyroid cancer;

there is active systemic autoimmune disease, which requires long-term treatment with immunosuppressants;

major surgery within 2 weeks before signing the informed consent, or major surgery planned during the study or within 4 weeks after giving the study treatment (excluding cataract and other local anesthesia surgery);

the investigator assessed that the participants were unable or unwilling to comply with the requirements of the study protocol, or were not suitable to participate in this clinical study for other reasons.

What this study is about