About this trial
This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia.
Eligibility criteria
Qualifiers
Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures.
Clinically diagnosed relapsed or refractory multiple myeloma or plasma cell leukemia (PCL). Patients with persistent minimal residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status following induction and consolidation therapy are also eligible for enrollment.
Age 18 to 80 years, inclusive.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
Disqualifiers
New York Heart Association (NYHA) Class III or IV heart failure;
Myocardial infarction;
Cardiac angioplasty or stent placement;
Unstable angina;
Trial design
Treatments tested in this trial
- IL-15-armored CAR-T cells