Actively Recruiting
Early Exploratory Clinical Study of CD19-targeted Gene Injection (LCAR02) in Patients With Relapsed/Refractory B-cell Lymphoma
Led by Anhui Provincial Hospital · Updated on 2026-01-21
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an Anti-CD19 gene injection for adults with relapsed or refractory B-cell lymphoma. This open-label, single-site study plans to include up to 18 participants to assess the safety and effectiveness of this gene therapy treatment. The study focuses on various aggressive types of B-cell lymphoma, including diffuse large B-cell lymphoma and mantle cell lymphoma, among others, in patients who have undergone at least two prior standard treatments without lasting remission. Participants will receive an intravenous infusion of the Anti-CD19 gene injection, tested across three dosage groups to explore the best therapeutic dose. The study involves dose escalation to evaluate safety and monitor treatment effects. The trial does not include a placebo group and is not blinded, meaning both researchers and participants know the treatment being given. During the study, participants will be closely monitored for adverse events and the behavior of the gene injection in the body, such as how long it stays and where it moves, up to one year after treatment. Researchers will also measure treatment responses including complete and objective response rates and the duration of response. Participants will undergo assessments like imaging tests to confirm measurable lesions and regular health evaluations to ensure vital organ function. The total follow-up period for outcomes extends to one year post-infusion.
CONDITIONS
Brief Title
Anti CD19 Gene Therapy for B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with specific types of B-cell lymphoma including diffuse large B-cell lymphoma, primary cutaneous DLBCL, primary mediastinal large B-cell lymphoma, ALK-positive anaplastic large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma, T-cell-rich B-cell lymphoma, transformed follicular lymphoma, follicular lymphoma, mantle cell lymphoma, large cell transformation of CLL
- Previously received at least second-line standard treatment and did not achieve remission or relapsed after remission
- At least one measurable lesion at baseline confirmed by PET-CT or CT imaging
- Tumor cells confirmed CD19 positive by immunohistochemistry
- Adequate vital organ function with specific liver, kidney, heart, lung function criteria
- ECOG performance status 0-2
- Expected survival greater than 3 months
- Female and male participants of childbearing potential must agree to use reliable contraception from consent until 2 years after infusion
You will not qualify if you...
- History of central nervous system diseases or pathological changes within 6 months before screening including stroke, epilepsy, severe brain injury, dementia, Parkinson's disease, or mental disorders
- Malignant tumors other than B-cell lymphoma
- Received vaccines or B-cell targeted therapy within 4 weeks before screening
- Systemic autoimmune diseases or immunodeficiency
- Grade 2-4 acute graft-versus-host disease or moderate to severe chronic GVHD within 4 weeks before screening
- Severe heart disease such as angina, myocardial infarction, heart failure, or arrhythmia
- History of severe allergies to study drugs or excipients
- Active hepatitis B, HCV antibody positivity, HIV antibody positivity, or positive for syphilis
- Active infections requiring intravenous antibiotics or hospitalization
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive an intravenous infusion of Anti-CD19 gene injection in one of three dosage groups.
Visits scheduled as needed for treatment administration and monitoring
Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
Research Team
W
wang xing bing, M.D
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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