A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma
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;
• intolerance during the last treatment, or the investigator assessed the need for new treatment after the last treatment;
• meet at least one of the following conditions:
‣ According to CT measurement: the long diameter of intranodal lesions is \>1.5 cm, or the long diameter of extranodal lesions is \>1.0 cm, and the short diameter can be measured;
⁃ According to PET measurement: FDG uptake score reaches 4 or 5;
• estimated survival \>12 weeks;
• Eastern Cooperative Oncology Group (ECoG) score 0-1;
• participants should meet the following test results (they have not received any granulocyte colony-stimulating factor (G-CSF) / granulocyte macrophage colony-stimulating factor (GM-CSF) treatment and supportive treatment of red blood cell and platelet transfusion within 7 days before laboratory examination):
‣ ;
⁃ Endogenous creatinine clearance ≥ 50 ml/min (using Cockcroft Gault formula), or creatinine ≤ 1.5 × ULN;
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; If lymphoma invades the liver: AST and alt ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;
⁃ The international normalized ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN.
⁃ Blood oxygen saturation in non oxygen inhalation state ≥ 92%;
⁃ Left ventricular ejection fraction (LVEF) ≥ 50% (LVEF value is near the critical value, and can be enrolled after the investigator has fully assessed the risk);
• female participants with childbearing potential must have a pregnancy test at the time of screening and the result is negative. They are willing to use very effective and reliable methods of contraception within 1 year after receiving study treatment. It is absolutely prohibited to donate eggs within 1 year after receiving study treatment infusion during the study period; Male participants who had active sex with women with reproductive potential were willing to use very effective and reliable methods of contraception within 1 year after receiving study treatment. All male participants were absolutely forbidden to donate sperm within 1 year after receiving study treatment infusion during the study period.