Actively Recruiting
A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-04-23
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
C
CARsgen Life Sciences Co.,Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating CT1182, an in vivo CAR-T cell therapy, in patients with relapsed or refractory B-cell Non Hodgkin Lymphoma (r/r B-NHL). This early phase 1, open-label study aims to explore the safety, effectiveness, metabolic behavior, and pharmacodynamics of CT1182 cells. The study intends to identify the maximum tolerated dose (MTD) by testing four dose levels, with a target toxicity probability of 30%, to understand how the treatment affects patients with various subtypes of B-NHL. Participants will receive intravenous infusions of CT1182 at escalating dose levels ranging from 1.2 × 10^8 to 1.2 × 10^9 TU. The dose escalation follows a Bayesian Optimal Interval design, with safety monitored over a 28-day dose-limiting toxicity (DLT) observation period after the first infusion. If no DLT is observed, doses may be adjusted; if ineffective expansion of CAR-T cells is detected, early withdrawal or continued safety observation is possible. The study plans to enroll between 3 and 24 participants, with dosing and cohort size adjusted according to ongoing results. During the study, participants will be closely monitored for adverse events, DLTs, and response rates for up to 24 months after infusion. Evaluations include clinical assessments, laboratory tests, and measurement of CAR gene copy numbers at multiple timepoints. Outcome measures include safety profiles, objective and complete response rates, duration and time to remission, progression-free survival, overall survival, and metabolic kinetics of the lentiviral vectors used in treatment. The study follows participants through long-term safety and efficacy assessments to better understand CT1182's impact.
CONDITIONS
Brief Title
A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years inclusive
- Diagnosed with relapsed or refractory B-cell Non Hodgkin Lymphoma by histology or cytology, including DLBCL, high-grade B-cell lymphoma, grade 3B follicular lymphoma, transformed follicular lymphoma, primary mediastinal large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma
- Previously received standardized systemic treatment including anti-CD20 drugs (unless CD20 negative) and anthracyclines
- Intolerance to last treatment or investigator assesses need for new treatment
- Meet at least one of the following: intranodal lesions >1.5 cm or extranodal lesions >1.0 cm by CT, or PET FDG uptake score 4 or 5
- Estimated survival greater than 12 weeks
- ECOG score 0-1
- Meet specified laboratory test requirements including creatinine clearance, liver enzymes, coagulation, oxygen saturation, and cardiac function
- Female participants with childbearing potential must have negative pregnancy test and use effective contraception for 1 year after treatment
- Male participants with reproductive potential must use effective contraception for 1 year after treatment
You will not qualify if you...
- Pregnant or lactating women
- History of neurological diseases or suspected central nervous system metastasis
- Infection with HIV, syphilis, active hepatitis B or C
- Uncontrolled active infections including tuberculosis
- Known or suspected long-term active EBV infection or history of HLH
- Autologous stem cell transplantation within 3 months or allogeneic stem cell transplantation previously
- Previous treatment targeting CD19 unless target test remains positive
- Prior treatment with pseudotyped viral vector therapies involving vesicular stomatitis virus glycoprotein
- Anti-tumor treatment within 14 days or 5 half lives before infusion
- Systemic glucocorticoids equivalent to >15 mg/day prednisone within 7 days before consent
- Vaccination within 4 weeks before consent or expected vaccination during or within 12 months after infusion
- Known allergy or intolerance to CT1182 or related components
- Significant cardiac diseases including severe heart failure, recent myocardial infarction, unstable angina, uncontrolled arrhythmias
- Serious lung disease posing safety risk
- Second primary malignant tumor requiring treatment or incomplete remission in past 3 years (with some exceptions)
- Active systemic autoimmune disease requiring long-term immunosuppressants
- Major surgery within 2 weeks before consent or planned during study period
- Investigator assessment of inability or unwillingness to comply with study protocol or other unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days after first infusion
Participants receive an infusion of CT1182 injection to explore safety, efficacy, and metabolic kinetics of the treatment.
Multiple visits for assessments up to 28 days after infusion
Duration - Up to 24 months
Participants are monitored for safety and treatment effects up to 24 months after CT1182 infusion.
Regular assessments at various time points including 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months, and 24 months after infusion
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
H
Heng Mei, M.D., Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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