Phase
Condition
Bone Diseases
Bone Neoplasm
Lymphoproliferative Disorders
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, immunomodulatoryagents, 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 enrollmentin this 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,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 inthe study 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
AustraliaSite Not Available
Cabrini Health
Melbourne, Victoria
AustraliaSite Not Available
Epworth Healthcare
Richmond, Victoria 3121
AustraliaSite Not Available
One Clinical Research (OCR)
Nedlands, Western Australia 6009
AustraliaSite Not Available
Beijing Jishuitan Hospital
Beijing, Beijing 100035
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200020
ChinaSite Not Available
Peking University, Third Hospital
Beijing,
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou,
ChinaSite Not Available
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou,
ChinaSite Not Available
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan,
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou,
ChinaSite Not Available

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