Actively Recruiting
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research
Led by Zhejiang University · Updated on 2024-12-04
36
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
L
Leman Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Non-Hodgkin lymphoma
CONDITIONS
Official Title
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before screening
- Age between 19 and 70 years, any gender
- Diagnosis of relapsed or refractory indolent B-cell lymphoma or diffuse large B-cell lymphoma
- Previous treatment including standard and salvage regimens with rituximab or CD20 antibody and at least two other appropriate regimens, one with anthracyclines
- Disease stable less than or equal to 12 months or progressing after treatment
- Recurrence after autologous or allogeneic stem cell transplantation or unable to receive transplantation
- Patients with double or triple-strike B-cell lymphoma unresponsive to second-line therapy
- Positive CD19 expression confirmed by immunohistochemistry or flow cytometry
- At least one measurable lesion at baseline
- Expected survival time longer than 12 weeks
- ECOG performance status 0-1
- Adequate organ function including blood counts, liver and kidney tests, coagulation, and lung function
- Left ventricular ejection fraction 45% or higher by echocardiography or MUGA
- Discontinuation of therapeutic steroids and immunosuppressive agents before infusion as specified
- Recovery from prior treatment toxicity to CTCAE grade less than 1 (some exceptions allowed)
- Women of childbearing potential and all male patients agree to use effective contraception for at least 12 months after infusion
You will not qualify if you...
- History or presence of central nervous system diseases unrelated to leukemia or lymphoma such as seizures, stroke, dementia, cerebellar disease, or autoimmune CNS disorders
- Chemotherapy other than preconditioning chemotherapy within 2 weeks before infusion
- Participation in other clinical trials within 30 days before enrollment
- Active hepatitis B or C infection
- Positive HIV or treponema pallidum antibody test
- Uncontrolled severe infections before infusion
- Recent unstable angina, myocardial infarction, thrombotic events, major bleeding, or deep vein thrombosis within specified time frames
- History of other cancers unless adequately treated and in remission as specified
- Pregnant or breastfeeding women
- History of prolonged QT interval or severe heart disease
- Significantly positive ADA (FMC63) test before consent
- Other conditions judged by investigators to preclude participation
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 medical college of zhejiang university
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
M
Mingming Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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