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 Aibin Liang，MD，Ph.D. · Updated on 2025-01-03
24
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and cellular metabolism of CT1190B CAR-T cell therapy in adults with relapsed or refractory B-cell Non-Hodgkin lymphoma (B-NHL). This Phase 1, open-label study aims to understand how CT1190B cells behave in the body and impact the disease. The trial plans to enroll between 6 and 24 participants who have previously undergone treatment for B-NHL but need further therapy due to disease progression or intolerance to prior treatments. Participants will receive an infusion of CT1190B CAR-T cells designed to target their cancer. This single-arm study involves one treatment group receiving this experimental therapy. The study includes close monitoring for adverse events and determination of the maximum tolerated dose within 28 days after infusion. Follow-up evaluations will continue for up to 12 months to assess response rates, remission duration, survival outcomes, and other key measures. During the trial, participants will undergo regular assessments including physical exams, laboratory tests, and imaging to measure tumor response and monitor safety. Researchers will track overall response rate, complete remission rate, progression-free survival, and overall survival at various intervals up to one year. Participants are required to agree to long-term follow-up for up to 15 years to monitor ongoing effects. Total involvement includes the treatment period plus extended safety and outcome monitoring.
CONDITIONS
Brief Title
A Clinical Study Exploring CT1190B in the Treatment of Patients with Relapsed/refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign the informed consent form and agree to long-term follow-up for up to 15 years.
- Age between 18 and 75 years.
- Histologically or cytologically confirmed B-cell Non-Hodgkin lymphoma.
- Previously received at least two lines of systemic therapy.
- Intolerance to last treatment or disease progression requiring therapy.
- Presence of measurable target lesions.
- Expected survival greater than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Female participants of childbearing potential must have a negative pregnancy test and agree to use reliable contraception for one year after treatment; male participants must also agree to use contraception for one year after treatment.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Infection with HIV, syphilis, active hepatitis B or hepatitis C virus.
- Current uncontrolled active infection, including active tuberculosis.
- Unresolved toxicities from prior treatments greater than Grade 1, except for alopecia or tolerable events.
- Treatment for the disease within 14 days before consent, including various therapies and investigational agents.
- Use of systemic glucocorticoids above 15 mg/day prednisone equivalent within 7 days prior to consent.
- Vaccination with live or inactivated vaccines within 4 weeks before consent.
- Allergy or intolerance to preconditioning drugs or tocilizumab or history of severe allergies.
- Heart disease within 6 months before screening.
- Oxygen saturation below 92%.
- Presence of a second primary cancer requiring treatment or not in remission within 2 years.
- Major surgery within 2 weeks before consent or planned during the study or within 4 weeks after treatment, excluding local anesthesia.
- Inability or unwillingness to comply with study requirements or deemed unsuitable by the 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 CT1190B CAR-T cell therapy through a single infusion to treat relapsed or refractory B-cell Non-Hodgkin lymphoma.
1 infusion visit and multiple follow-up visits during treatment period
Duration - 12 months after CT1190B infusion
Participants are monitored for safety, efficacy, and overall health outcomes for up to 12 months after CT1190B infusion.
Visits at 4, 8, 12 weeks and 6, 9, 12 months after infusion
Trial Site Locations
Total: 1 location
1
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
Research Team
A
Aibin Liang MD,Ph.D.
P
Ping Li MD
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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