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.
Single group
KSVCBD injection
Biological/VaccineKSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA. Three dose levels are predefined, and KSVCBD will be dose-escalated per the protocol-specified doses
Dose limited toxicity (DLT)
DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
AEs refer to any adverse medical events occurring in subjects from the initiation of KSVCBD administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after KSVCBD administration in subjects
Incidence and severity of adverse events of special interest (AESI)
AESI including grade ≥ 3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections
Objective Response Rate (ORR)
ORR includes Complete Remission (CR) and Partial Remission (PR).
Duration of Response (DOR)
Time from first documented PR or better to relapse or disease progression, or death from any cause
Time to Response (TTR)
Time from administration to first documented PR or better.
Progression-Free Survival (PFS)
Time from administration to disease progression or death from any cause, whichever occurs first.
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