About this trial
This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation.
Eligibility criteria
Qualifiers
Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry
Patients with multiple myeloma, plasma cell carcinoma, plasma cell leukemia and lymphomas/leukemias with plasmacytic differentiation who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse
Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past [anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)], but have failed or experienced relapse
Age 18-80 years, no gender restrictions
Disqualifiers
Severe heart failure with left ventricular ejection fraction <50%
A history of severe lung function impairment
Combined with other advanced malignant tumors
Complicated with severe infection that could not be effectively controlled
Trial design
Treatments tested in this trial
- CAR19BCMA-T cells
- fludarabine and cyclophosphamide