This study is a single-center,open-label,single-dose clinical trial of anti-CD20/CD30-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after lymphocyte depletion pre-treatment.
In this study phase,a traditional "3+3"trial design is employed for dose escalation.
Best response of Stable Disease (SD) after at least 4 cycles of first-line treatment (e.g., 4 cycles of RCHOP), with SD maintenance duration not exceeding 6 months after the last dose.
PD as best response to the most recent treatment regimen
Best response of SD after at least 2 cycles of last-line treatment, with SD maintenance duration not exceeding 6 months after the last dose.
Disease progression or relapse ≤12 months after ASCT (relapsing subjects must have biopsy-proven relapse)
Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless CNS involvement has been effectively treated (i.e., participant is asymptomatic) and there has been a local treatment interval of >4 weeks prior to enrollment.
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 malignancies other than CD19+ malignancies.
Clinically significant cardiac disease, or arrhythmias not controlled by medication.
Single group
anti-CD20/CD30-CAR-T Cells
Biological/VaccineBefore cell infusion,researchers may decide, based on necessity, whether to administer prophylactic medication,which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after anti-CD20/CD30-CAR-T cell infusion,including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesice,etc.
Incidence of dose-limiting toxicity
The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities(DLTs). Safety evlauations are performed in accordance with the NCI-CTCAE version 5.0 standards(Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
