Anti-CD19 gene therapy for B-cell lymphoma
Official title: Early Exploratory Clinical Study of CD19-targeted Gene Injection (LCAR02) in Patients With Relapsed/Refractory B-cell Lymphoma
Run by Anhui Provincial Hospital · NCT07211048 · Data updated 2026-11-12
This trial will try an Anti-CD19 gene injection in adults with relapsed or refractory B-cell lymphoma to see if it is safe and can shrink tumors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | March 20, 2026 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07211048 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with relapsed or refractory aggressive or transformed B-cell lymphomas who have received at least second-line therapy and have at least one measurable lesion are the intended participants.
✕Probably not a fit
Patients who have not yet tried standard therapies, who lack a measurable lesion, or who have medical conditions that preclude gene therapy are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, single-site, dose-escalation trial enrolling up to 18 adults with relapsed or refractory B-cell lymphoma. Participants will receive escalating doses of an Anti-CD19 gene injection and will be closely monitored for adverse events and tumor response. Eligible patients must have received at least second-line standard treatment and have at least one measurable lesion per lymphoma staging guidelines. The study's primary focus is safety with secondary assessment of clinical activity.
Why it matters
Potential benefit: If successful, the treatment could offer a new option to induce remission in patients whose B-cell lymphoma has failed standard therapies.
How similar studies have gone: CD19-targeting gene therapies such as CAR-T products have produced durable remissions in relapsed/refractory B-cell lymphomas, so this approach builds on prior successful CD19-targeted strategies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1)Age 18 years or older, any gender; (2)Patients diagnosed with any of the following conditions: diffuse large B-cell lymphoma (DLBCL), germinal center or activated B-cell type; primary cutaneous DLBCL; primary mediastinal (thymic) 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; or any aggressive B-cell lymphoma arising from indolent lymphoma; follicular lymphoma; mantle cell lymphoma; large cell transformation of CLL. Patients must have previously received at least second-line standard treatment and either did not achieve remission or relapsed after remission; (3) For B-cell lymphoma patients, according to the preliminary assessment, staging, and response evaluation recommendations for Hodgkin and non-Hodgkin lymphomas (2014 edition), there must be at least one measurable lesion at baseline, which is defined as a lymph node lesion with a long diameter \>15 mm or an extranodal lesion with a long diameter \>10 mm, diagnosed by PET-CT or CT imaging; (4) B-cell lymphoma patients must have tumor cells confirmed CD19 positive by immunohistochemistry; (5) Adequate vital organ function: liver function meeting: ALT ≤3×ULN, AST ≤3×ULN; serum creatinine ≤140 μmol/L; total bilirubin ≤2×ULN, or ≤3×ULN in patients with Gilbert's syndrome; hemodynamically stable as determined by echocardiography or multi-gated radionuclide angiography (MUGA) with left ventricular ejection fraction (LVEF) ≥45%; no active pulmonary infection, and percutaneous arterial oxygen saturation ≥92% without supplemental oxygen; (6) ECOG performance status: 0-2; (7) Expected survival of more than 3 months; (8) Female and male participants of childbearing potential must agree to use reliable and effective contraception from the time of signing the informed consent form until 2 years after receiving LCAR02 infusion (excluding natural family planning methods). Exclusion Criteria: * (1) Patients who have experienced central nervous system diseases or pathological changes within 6 months before screening, including but not limited to: stroke, cerebrovascular accident, aneurysm, epilepsy, convulsions, aphasia, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndrome, or mental disorders. (2) Patients with malignant tumors other than B-cell lymphoma. (3) Patients who received vaccines or B-cell targeted therapy within 4 weeks before screening. (4) Patients with systemic autoimmune diseases or immunodeficiency. (5) Patients with grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening. (6) Patients with relatively severe heart disease, such as angina, myocardial infarction, heart failure, or arrhythmia. (7) Patients with a history of severe allergies to the drugs or excipients used in the clinical study or investigational drugs. (8) Patients with active hepatitis B, HCV antibody positivity, HIV antibody positivity, or positive for syphilis. (9) Patients with active infections requiring intravenous antibiotics or hospitalization. (10) Pregnant or breastfeeding women.
Where it's running
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Anhui Provincial Hospital
Hefei, Anhui, China Recruiting
Study contacts
- Study coordinator: wang xing bing, M.D
- Email: wangxingbing@ustc.edu.cn
- Phone: +86-0551-62284476
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.