Phase
Condition
Bone Diseases
Cancer/tumors
Bone Neoplasm
Treatment
EMB-06
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Able to understand and willing to sign the informed consent form (ICF)
- Patients who have been diagnosed with multiple myeloma according to IMWG diagnosticcriteria 2014 and have relapsed or refractory multiple myeloma with at least onemeasurable lesion.
- The patient must have received at least two lines (for patients in the US, at leastthree 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 thetrial.
- Highly effective contraception
Exclusion
Exclusion Criteria:
- Life expectancy is less than 3 months.
- Patient participated in any other clinical study within 1 month prior to enrollment inthis clinical study.
- Patients with ongoing AE.
- Previously treated with any BCMA-targeted therapy.(Exception: in Phase 2 portion, upto 10 patients who have received prior anti-BCMA ADC or BCMA targeted CAR-T can beenrolled)
- History of allogeneic stem cell transplantation.
- Previously treated with the following anti-tumor therapy (prior to first dosing ofEMB-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, whicheveris 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 thestudy regardless of the end date of radiation therapy
- Plasmapheresis within 7 days
- Patient received autologous stem cell transplantation within 12 weeks prior to thestart 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
Study Design
Study Description
Connect with a study center
Sunshine Coast Haematology and Oncology Clinic (SCHOC)
Buderim, Queensland 4556
AustraliaActive - Recruiting
Cabrini Health
Melbourne, Victoria
AustraliaSite Not Available
Epworth Healthcare
Richmond, Victoria 3121
AustraliaActive - Recruiting
One Clinical Research (OCR)
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing 100035
ChinaActive - Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200020
ChinaActive - Recruiting
Peking University, Third Hospital
Beijing,
ChinaActive - Recruiting
Guangdong Provincial People's Hospital
Guangzhou,
ChinaActive - Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou,
ChinaActive - Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan,
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou,
ChinaActive - Recruiting
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