NCT07548697 A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma
| NCT ID | NCT07548697 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | B-cell Non Hodgkin Lymphoma (NHL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-04-30 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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: 1. 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; 2. 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): 1. ; 2. Endogenous creatinine clearance ≥ 50 ml/min (using Cockcroft Gault formula), or creatinine ≤ 1.5 × ULN; 3. 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; 4. The international normalized ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN. 5. Blood oxygen saturation in non oxygen inhalation state ≥ 92%; 6. 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07548697 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying B-cell Non Hodgkin Lymphoma (NHL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07548697 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07548697 currently recruiting?
Yes, NCT07548697 is actively recruiting participants. Contact the research team at hmei@hust.edu.cn for enrollment information.
Where is the NCT07548697 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07548697 clinical trial?
NCT07548697 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 24 participants.