This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.
Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures.
Age ≥ 14 years and < 70 years.
No response to first-line treatment (primary refractory disease, excluding participants intolerant to first-line treatments).
Disease progression (PD) as assessed after first-line treatment.
MRI of the brain shows evidence of central nervous system lymphoma; active primary central nervous system DLBL, unless central nervous system involvement has been effectively treated (i.e., participant is asymptomatic), and there has been more than a 4-week gap since local treatment.
Active central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with central nervous system involvement.
History of or concurrent diagnosis of malignancies other than CD19+ malignancies.
Clinically significant heart disease or arrhythmias that cannot be controlled with medication.
Single group
anti-CD20/CD30-CAR-T cells
GeneticEach subject will be infused with single dose of anti-CD20/CD30-CAR-T cells. A classic "3+3" dose escalation will be employed.
Fludarabine
DrugFludarabine will be given at a dose of 25 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.
Cyclophosphamide
DrugCyclophosphamide will be given at a dose of 250 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.
Safety and tolerance
Incidence of dose-limiting toxicity (DLT)
Manufacturing feasibility
Percentage of subjects for whom the required dose of anti-CD20/CD30-CAR-T cells can be successfully manufactured.
Click on the lead sponsor to view all of their trials.
