KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) CD19 and/or BCMA.
Age 18-75 years (inclusive), any gender.
Diffuse large B-cell lymphoma, not otherwise specified.
Primary mediastinal large B-cell lymphoma.
Diffuse large B-cell lymphoma transformed from follicular lymphoma (TFL).
Expected survival < 3 months.
History of or concurrent active malignancy. Exceptions include: carcinoma in situ of the cervix that has been cured or with no recurrence for at least 3 years, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery.
Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) or autologous HSCT within 3 months prior to KSVCBD infusion.
Solitary extramedullary soft tissue plasmacytoma.