About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)