This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.
18 to 70 years old, male or female;
Revised Multiple Myeloma International Staging System (R-ISS) stage 3;
Double-hit or triple-hit according to FISH test.
The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;
Patient who needs chronic use of immunosuppressive agents;
Patient with hypertension that cannot be controlled by medication;
Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade III), severe arrhythmia;
Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases that require drug treatment;
Single group
Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)
DrugCT103A is a customized, BCMA-targeted genetically modified autologous T cell immunotherapy, which can identify and eliminate malignant and normal cells expressing BCMA. CAR specifically recognizes BCMA with single chain fragment variable (ScFv), and promotes the activation, proliferation, cytokine secretion and target cell killing of CAR-T through the CD3ζ domain. And 4-1BB enhances the expansion and persistence of CT103A. CT103A will be infused at 1.0×10\^6 /kg via intravenous drip within 24h to 72h after chemotherapy conditioning regimen at the recommended infusion rate of 3-5 mL/min.
Proportion of Minimal Residual Disease (MRD)-negative subjects
The proportion of subjects who achieve MRD-negativity after CT103A infusion.
Median progression-free survival (mPFS)
The median time from the date of CT103A infusion to the date of first disease progression or death from any cause.
Best overall response (BOR)
The proportion of subjects who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) after CT103A infusion.
Median survival (mOS)
The median time from the date of CT103A infusion to the date of death from any reason.
Event-free survival (EFS)
The time from date of CT103A infusion to the date of death from any reason, relapse, treatment failure, disease progression or initiation of other anti-tumor treatment, whichever comes first;
Duration of response (DOR)
The time from the first assessment of sCR or CR or VGPR or PR to the first assessment of disease progression or death from any cause;
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