Actively Recruiting
A Clinical Study Investigating Safety, Efficacy, and Cellular Effects of CT1190B CAR-T Cell Therapy in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Led by Aibin Liang，MD，Ph.D. · Updated on 2025-01-03
24
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This phase 1, single-arm, open-label study aims to evaluate the safety, effectiveness, and cellular behavior of CT1190B cells in this patient group. The study plans to enroll between 6 and 24 participants with measurable disease who have previously received at least two lines of systemic therapy and require further treatment due to intolerance or disease progression. Participants will receive infusions of CT1190B chimeric antigen receptor T cells. The study focuses on exploring the appropriate dose range and maximum tolerated dose of CT1190B. Treatment effects, safety, and cellular pharmacokinetics will be assessed during and following the infusion period. There is no comparator group, as this is an exploratory dose-finding study. During the study, participants will be closely monitored for adverse events up to 12 months after the CT1190B infusion and for dose-limiting toxicities within 28 days post-infusion. Assessments include clinical evaluations, laboratory tests, and long-term follow-up for up to 15 years as required by regulatory guidelines. The study also includes monitoring for potential side effects and treatment responses to understand the therapy's safety and efficacy better.
CONDITIONS
Official 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 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
- 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 score of 0 or 1
- Female participants of childbearing potential must have a negative pregnancy test before preconditioning therapy and agree to use effective contraception for 1 year after treatment; male participants must use effective contraception for 1 year after treatment and avoid sperm donation during this time
You will not qualify if you...
- Pregnant or lactating women
- HIV, syphilis infection, active hepatitis B or C virus infection
- Uncontrolled active infections including active tuberculosis
- Toxicities from previous treatments not resolved to grade 1 or less, except alopecia and other tolerable events
- Received treatment for the disease within 14 days before informed consent, except limited radiotherapy
- Use of systemic glucocorticoids equivalent to more than 15 mg/day prednisone within 7 days prior to informed consent, except topical glucocorticoids
- Vaccination with live attenuated, inactivated, or RNA vaccines within 4 weeks prior to informed consent
- Allergy or intolerance to preconditioning drugs or tocilizumab or history of severe allergy
- Heart disease within 6 months prior to screening
- Oxygen saturation below 92%
- Presence of a second primary malignancy requiring treatment or not in remission within past 2 years
- Major surgery within 2 weeks before informed consent or planned during the study or within 4 weeks after treatment, excluding local anesthesia
- Unable or unwilling to comply with study protocol or deemed unsuitable by investigator
AI-Screening
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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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