Actively Recruiting
Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma
Led by The First Affiliated Hospital of Soochow University · Updated on 2024-04-24
64
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
S
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.
CONDITIONS
Official Title
Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Confirmed relapsed or refractory Large B-cell Non-Hodgkin's Lymphoma with measurable lesions (longest diameter >1.5 cm and vertical diameter >1.0 cm)
- Previously treated with one or more lines of therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Heart function with left ventricular ejection fraction (LVEF) of 50% or higher
- Kidney function with creatinine clearance (CCr) of 30 ml/min or higher
- Liver enzymes (ALT and AST) no more than 3 times the normal range
- Blood counts including platelet count of 45 x 10^9/L or higher, hemoglobin of 8.0 g/dL or higher, and absolute neutrophil count of 1.0 x 10^9/L or higher
- Willingness to use birth control during the study and for one year after
- Estimated survival time of 3 months or more
- Voluntary informed consent and good compliance
You will not qualify if you...
- Use of immunosuppressants or hormones within 2 weeks before apheresis or planned use after consent
- Presence of difficult-to-control bacterial, fungal, viral, mycoplasma, or other infections
- Active hepatitis B or hepatitis C infection
- HIV infection
- Previous CAR-T cell therapy or allogeneic stem cell transplantation before consent
- Previous cancer other than relapsed/refractory B-cell Non-Hodgkin's Lymphoma
- Pregnant or breastfeeding women
- Serious complications or medical conditions posing high risk or interfering with study conduct, including serious cardiovascular disease
- Any condition deemed inappropriate for study participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
C
Caixia Li, M.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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