Actively Recruiting
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research
Led by He Huang · Updated on 2025-09-19
18
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
H
He Huang
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 Diffuse Large B-Cell Lymphoma
CONDITIONS
Official Title
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient or guardian has voluntarily signed informed consent
- Adult patients diagnosed with relapsed or refractory diffuse large B-cell lymphoma, including primary mediastinal large B-cell lymphoma and transformed follicular lymphoma
- Refractory disease defined as no response to last treatment with progression or stable disease lasting 6 months or less
- Not suitable for or refractory to autologous hematopoietic stem cell transplantation (ASCT), including progression or recurrence within 12 months after ASCT
- Previously received at least two lines of therapy including anthracycline-containing chemotherapy
- For transformed DLBCL from follicular lymphoma, prior chemotherapy for follicular lymphoma and refractory disease after transformation
- Patients with double-strike or triple-strike lymphoma unresponsive to second-line treatment
- Positive CD19 expression confirmed by immunohistochemistry or flow cytometry
- At least one measurable lesion at baseline
- Expected survival time greater than 12 weeks
- Baseline ECOG performance status of 0 or 1
- Adequate organ function as defined by specified kidney, liver, pulmonary, and cardiac criteria
- Stable use of steroids and immunosuppressive agents as specified
- Recovery from previous treatment toxicities to CTCAE grade less than 1 (with some exceptions)
- Women of childbearing potential and male patients agree to effective contraception for at least 12 months after infusion and until two consecutive PCR tests show no CAR T cells in vivo
You will not qualify if you...
- History or current central nervous system diseases including seizures, stroke, dementia, cerebellar disease, or autoimmune CNS diseases
- History of allogeneic hematopoietic stem cell transplantation
- Chemotherapy other than preconditioning within 2 weeks prior to infusion
- Participation in other clinical trials within 30 days prior to enrollment
- Active hepatitis B or C infection
- Positive HIV or treponema pallidum antibody tests
- Uncontrolled acute life-threatening infections
- Unstable angina or myocardial infarction within 6 months
- History of other malignancies except adequately treated skin cancer, carcinoma in situ of cervical or breast cancer with no recurrence for 3 years, or primary malignancy in remission for 5 years
- Pregnant or breastfeeding women
- Active neuroautoimmune or inflammatory conditions
- Other conditions deemed unsuitable by the investigator such as poor compliance
AI-Screening
AI-Powered Screening
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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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