This Phase I/II trial is trying to understand how safe and tolerable a new targeted therapy drug (EMB-06) is in people who have multiple myeloma that has come back or is resistant to other treatmentA First-in-human, Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of EMB-06 in Patients With Recurrent or Refractory Multiple Myeloma

Exclusion

• Life expectancy is less than 3 months.
• Patient participated in any other clinical study within 1 month prior to enrollment in this clinical study.
• Patients with ongoing AE.
• Previously treated with any BCMA-targeted therapy.(Exception: in Phase 2 portion, up to 10 patients who have received prior anti-BCMA ADC or BCMA targeted CAR-T can be enrolled)
• History of allogeneic stem cell transplantation.

• Previously treated with the following anti-tumor therapy (prior to first dosing of EMB-06)

  1. Treated with monoclonal antibody for multiple myeloma within 28 days
  2. Treated with proteasome inhibitors within 14 days
  3. Treated with immunomodulatory agents within 14 days
  4. Treated with cytotoxic therapy within 14 days
  5. Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
  6. Received radiotherapy within 21 days. Except that the radiation portal covered ≤ 5% of the bone marrow reserve, the patient will be eligible to participate in the study regardless of the end date of radiation therapy
  7. Plasmapheresis within 7 days
• Patient received autologous stem cell transplantation within 12 weeks prior to the start of study treatment.
• Active or historically multiple myeloma related central nervous system involvement.
• Patients requiring high dose of systemic treatment with corticosteroids.
• Patients with active infections, including COVID-19, hepatitis, etc..
• History of severe allergic reactions
• Patients with severe or uncontrolled cardiovascular disorder requiring treatment
• Pre-existing other serious medical conditions