About this trial
This is a single arm study to evaluate the safety and efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for Relapsed/Refractory B-Cell Lymphoma
Eligibility criteria
Qualifiers
The subject has voluntarily signed the informed consent form with full consent, and is willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures
Lymphoma cells confirmed to express CD19 and/or CD20 antigen by immunophenotyping or histopathological immunohistochemistry
B-cell lymphomas include: aggressive B-cell lymphomas (LBCL, BL, MCL) and indolent B-cell lymphomas (CLL/SLL, FL, MZL, LPL, HCL)
Relapsed/refractory B-cell lymphoma: For patients with aggressive lymphoma, disease stable for ≤12 months or disease progression after achieving best response following at least first- and second-line pharmacotherapy; or disease progression or relapse within ≤12 months after autologous stem cell transplantation. For patients with indolent lymphoma, disease progression, relapse or transformation following at least three lines of prior therapy
Disqualifiers
Severe cardiac insufficiency with left ventricular ejection fraction < 50%
History of severe pulmonary function-impairing diseases
Concomitant other advanced malignant neoplasms
Concomitant severe infection that cannot be effectively controlled
Trial design
Treatments tested in this trial
- CD19/CD20 Tandem Dual CAR-T