Actively Recruiting
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Led by Tongji Hospital · Updated on 2025-11-17
27
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, efficacy, and cellular metabolism of CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This clinical study is a single-arm, open-label, dose exploratory trial designed to enroll between 6 and 24 participants. It aims to assess how these CAR-T cells behave and affect the disease in this patient population under medical supervision. Participants will receive infusions of CT1190B and CT1190B-P cells as the experimental treatment. The study does not include a comparison group and focuses on evaluating the dose range and maximum tolerated dose within 28 days after infusion. The treatment involves a single-arm administration of chimeric antigen receptor T cells, and participants will be followed for up to 12 months to monitor responses and safety outcomes. Throughout the study, participants will undergo various assessments including monitoring of the dose effects, overall and complete response rates at multiple time points (4, 8, 12 weeks and 6, 9, 12 months), duration of remission, progression-free survival, and overall survival up to 12 months after treatment. Participants must adhere to a long-term follow-up plan extending up to 15 years as required by regulatory guidelines. Safety evaluations and cellular pharmacokinetics will also be monitored during the study period.
CONDITIONS
Brief Title
A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign the informed consent form and agree to follow the study schedule and long-term follow-up for up to 15 years.
- Age between 18 and 75 years.
- Histologically or cytologically confirmed B-cell Non-Hodgkin Lymphoma based on WHO classification, including specific lymphoma subtypes.
- Previous treatment: at least 2 prior lines of systemic therapy including anti-CD20 drugs or chemotherapy, depending on lymphoma subtype.
- Intolerance to last treatment or disease progression requiring therapy.
- Presence of measurable lesions by CT, MRI, or PET-CT per defined criteria.
- Expected survival greater than 12 weeks.
- ECOG performance status 0-1 (0-3 for primary CNS lymphoma).
- Adequate blood counts and organ function as specified.
- Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception for 1 year post-treatment; male participants must also agree to contraception and avoid sperm donation for 1 year post-treatment.
You will not qualify if you...
- Pregnant or lactating women.
- Presence of HIV, syphilis, active hepatitis B or C infection.
- Any uncontrolled active infection including tuberculosis.
- Unresolved toxicities from prior treatments above grade 1 except tolerable events.
- Autologous stem cell transplant within 12 weeks prior to consent.
- Prior therapy targeting CD19 unless target remains positive.
- Recent treatment within 14 days before preconditioning including chemotherapy, monoclonal antibodies, radiotherapy, or investigational agents.
- Systemic glucocorticoids over 15 mg/day prednisone equivalent within 7 days before consent.
- Vaccination with live, inactivated, or RNA vaccines within 4 weeks prior to consent.
- Allergy or intolerance to preconditioning drugs, tocilizumab, or CT1190B infusion components.
- Recent serious cardiac conditions or diseases that may pose risk.
- Oxygen saturation below 92% or serious lung diseases.
- Presence of a second primary malignancy requiring treatment or not in remission within past 2 years, except certain low malignancy tumors.
- Major surgery within 2 weeks before consent or planned within study period except minor procedures.
- Inability or unwillingness to comply with study requirements or unsuitable as judged by investigator.
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 - Up to 28 days after CAR-T cells infusion
Participants receive infusions of CT1190B and CT1190B-P CAR T cells and are monitored for safety and efficacy during the treatment period.
Multiple visits during the first 28 days post-infusion
Duration - 12 months after CAR-T cells infusion
Participants are followed for up to 12 months after CAR-T cell infusion to assess treatment response and long-term outcomes.
Visits at 4, 8, 12 weeks and 6, 9, 12 months after infusion
Trial Site Locations
Total: 1 location
1
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhang, Hubei, China, 430030
Actively Recruiting
Research Team
Y
Yicheng Zhang MD,Ph.D., MD
Y
Yicheng Zhang MD, 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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