Phase
Condition
Multiple Myeloma
Cancer/tumors
Lymphoproliferative Disorders
Treatment
SIM0500
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation and signature of informed consent form.
≥18 years of age.
Have documented diagnosis of relapsed or refractory multiple myeloma according toCriteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria whohave failed all established standard of care.
Life expectancy ≥12 weeks.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Adequate hematologic, hepatic, and renal function.
Exclusion
Exclusion Criteria:
Toxicities from previous anticancer therapies should have resolved to baselinelevels or to Grade 1 or less except for alopecia or peripheral neuropathy.
Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies/mL or ≥ 2,000international unit [IU]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN)infection; participant with HBsAg positive or detective HBV-DNA at screening shouldreceive antiviral treatment as per local practice during the trial.
Known human immunodeficiency virus (HIV) infection or acquired immunodeficiencysyndrome (AIDS).
Participant is pregnant or breastfeeding, or expecting to conceive or fatherchildren within the projected duration of the trial.
Active known or suspected autoimmune disease. Participants with vitiligo, residualhypothyroidism only requiring hormone replacement, psoriasis not requiring systemictreatment or conditions not expected to recur in the absence of an external trigger,type 1 diabetes mellitus (blood glucose can be controlled by insulin therapy) can beincluded.
Current or previous other malignancy within 3 years of study entry, except basal orsquamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of theprostate, cervix or breast.
Known active central nervous system (CNS) involvement or exhibits clinical signs ofmeningeal involvement of multiple myeloma.
Participants with known active infection within 14 days prior to the first SIM0500.
Study Design
Connect with a study center
Beijing Chaoyang Hospital Capital Medical University
Beijing, Beijing 100000
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaActive - Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin 300000
ChinaActive - Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang 310000
ChinaActive - Recruiting
Dana Farber Cancer institution
Boston, Massachusetts 02215
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute
New York, New York 10029
United StatesActive - Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
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