A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Pat⦠(NCT07548697) | Clinical Trial Compass
RecruitingEarly Phase 1
A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma
China24 participantsStarted 2026-04-30
Plain-language summary
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).
Who can participate
Age range18 Years β 75 Years
SexALL
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Inclusion criteria
β. 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;
β. According to PET measurement: FDG uptake score reaches 4 or 5;
β. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) β€ 3 Γ ULN, total bilirubin β€ 1.5 Γ ULN; If lymphoma invades the liver: AST and alt β€ 5 Γ ULN, total bilirubin β€ 3.0 Γ ULN;
β. The international normalized ratio (INR) and activated partial thromboplastin time (APTT) should be β€ 1.5 Γ ULN.
β. Blood oxygen saturation in non oxygen inhalation state β₯ 92%;
β. Left ventricular ejection fraction (LVEF) β₯ 50% (LVEF value is near the critical value, and can be enrolled after the investigator has fully assessed the risk);
Exclusion criteria
β. The New York Heart Association (NYHA) cardiac function classification was grade III or IV heart failure;
β. Myocardial infarction, unstable angina pectoris, or coronary artery bypass grafting or coronary stent implantation occurred within 6 months before screening;
β. There is a history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;
What they're measuring
1
Frequency, type and severity of AES
Timeframe: Within 24 months after CT1182 infusion
2
The number and severity of dose-limiting toxicity (DLT)events
Timeframe: Within 28 days after CT1182 infusion
Trial details
NCT IDNCT07548697
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology