This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.
In this study phase, a traditional "3+3" trial design is employed for dose escalation.
Voluntary participation in the clinical trial; the individual or legal guardian fully understands and consents to the study by signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.
Age between 18-70 years.
Patients who are refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and not suitable for other treatment options such as a second hematopoietic stem cell transplantation.
Relapse or refractory disease after two or more lines of systemic therapy
CD19-targeted therapy.
Use of chlorambucil or cladribine within 3 months prior to enrollment, or use of PEG-asparaginase within 3 weeks prior to enrollment.
Injection of live vaccines within 4 weeks prior to enrollment.
Donor lymphocyte infusion (DLI) within 28 days prior to enrollment.
Single group
anti-CD19-CAR-T cells
Biological/VaccineBefore cell infusion, Investigator 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-CD19-CAR-T cell infusion, including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesics, etc.
Incidence of dose-limiting toxicity
The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities (DLTs). Safety evaluations 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).
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