Actively Recruiting
A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 )
Led by Tongji Hospital · Updated on 2025-11-17
27
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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's Lymphoma.
CONDITIONS
Official 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 informed consent and agree to adhere to the study schedule and long-term follow-up for up to 15 years
- Age between 18 and 75 years old
- Histologically or cytologically confirmed B-cell Non-Hodgkin's Lymphoma subtypes as defined by WHO criteria
- Previous treatment: at least 2 prior lines of systemic therapy including anti-CD20 drugs and chemotherapy for most cohorts, or at least 1 line for primary central nervous system lymphoma
- Intolerance to last treatment, or disease progression requiring new therapy
- Presence of measurable disease by CT, MRI, or PET-CT imaging or treatment requirement for chronic lymphocytic leukemia
- Expected survival greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (0-3 for primary CNS lymphoma)
- Adequate blood counts and organ function as specified
- Negative pregnancy test for females of childbearing potential and agreement to use contraception for 1 year after treatment; males must also agree to use contraception for 1 year
You will not qualify if you...
- Pregnant or lactating women
- Active infections including HIV, syphilis, active hepatitis B or C infections
- Any uncontrolled active infection including tuberculosis
- Unresolved toxicities from prior treatments greater than Grade 1 except alopecia
- Autologous stem cell transplantation within 12 weeks prior to consent
- Prior therapy targeting CD19 unless tumor remains CD19 or CD20 positive
- Treatment for lymphoma within 14 days or 5 half-lives prior to preconditioning
- Systemic glucocorticoids greater than 15 mg/day prednisone equivalent within 7 days prior to consent
- Vaccination with live, inactivated, or RNA vaccines within 4 weeks prior to consent
- Allergy or intolerance to study drugs or infusion components
- Significant cardiac conditions within 6 months prior to screening
- Oxygen saturation below 92% or serious lung disease
- Second primary malignancy requiring treatment or not in remission within 2 years except specific low-risk cancers
- Major surgery within 2 weeks before consent or planned during the study period or within 4 weeks after treatment
- Unable or unwilling to comply with study requirements or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
Y
Yicheng Zhang MD, Ph.D
CONTACT
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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