About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- anti-CD19-CAR-T cells