Status:
TERMINATED
A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma
Lead Sponsor:
Shanghai EpimAb Biotherapeutics Co., Ltd.
Conditions:
Relapsed or Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 RP...
Detailed Description
This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Pha...
Eligibility Criteria
Inclusion
- Able to understand and willing to sign the informed consent 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 antibody) of prior antimyeloma therapies, and must have received treatment with proteasome inhibitors, 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
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)
- Treated with monoclonal antibody for multiple myeloma within 28 days
- Treated with proteasome inhibitors within 14 days
- Treated with immunomodulatory agents within 14 days
- Treated with cytotoxic therapy within 14 days
- Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
- 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
- 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
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04735575
Start Date
May 20 2021
End Date
August 20 2024
Last Update
May 28 2025
Active Locations (10)
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1
Sunshine Coast Haematology and Oncology Clinic (SCHOC)
Buderim, Queensland, Australia, 4556
2
Epworth Healthcare
Richmond, Victoria, Australia, 3121
3
One Clinical Research (OCR)
Nedlands, Western Australia, Australia, 6009
4
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China, 100035