Brief Summary
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed.
Intervention / Treatment
- Biological: EMB-06
Inclusion Criteria
- Able to understand and willing to sign the informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. form (ICF)
- Patients who have been diagnosed with multiple myeloma according to IMWG diagnostic criteria 2014 and have relapsed or refractory multiple myeloma with at least one measurable lesion.
- The patient must have received at least two lines (for patients in the US, at least three lines which should include anti-CD38 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses) of prior antimyeloma therapies, and must have received treatment with proteasome inhibitorsmedication that inhibits the action of proteasomes, which are substances that break down proteins in the body, immunomodulatory agents, and if accessible, an anti-CD38 targeting monoclonal antibody.
- ECOG performance status 0 or 1 for phase I, and ≤2 for phase II.
- Adequate organ function and reasonable laboratory test results to participate in the trial.
- Highly effective contraception