This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.
The subject or their legally acceptable representative has provided written informed consent and is willing and able to comply with all scheduled study visits, study treatment administration, laboratory tests, and other required trial procedures.
Deletion of the short arm of chromosome 17 (del(17p)) with clonal proportion ≥ 20%, and/or TP53 gene mutation;
IgH translocation (t(4;14), t(14;16), or t(14;20)) combined with 1q amplification (1q+) and/or deletion of the short arm of chromosome 1 (del(1p32));
Chromosome 1 abnormalities: monoallelic del(1p32) plus 1q+, or biallelic del(1p32);
Severe cardiac insufficiency with left ventricular ejection fraction (LVEF%) < 50%.
History of severe chronic lung disease associated with impaired pulmonary function.
Concurrent active or progressive malignant tumors other than the target plasma cell neoplasm.
Concurrent severe infection that cannot be effectively controlled with standard therapy.