Status:
RECRUITING
Anti CD19 Gene Therapy for B-cell Lymphoma
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed/refractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the tre...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07211048
Start Date
October 20 2025
End Date
December 31 2029
Last Update
October 7 2025
Active Locations (1)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001