Tests SIM0500 in adults with relapsed or refractory multiple myeloma
Tests SIM0500, a new antibody medicine, in adults with returning myeloma.
Plain-language title generated from the registry record
Registry title: Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Beijing, Fuzhou, Guangzhou, Hanzhou, Nanjing, Tianjin, and Zhengzhou, ChinaSee the 7 sites
- Phase
- Phase 1
Where in China
- Beijing Chaoyang Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaTaking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
- The First Affiliated Hospital, Zhejiang University School of MedicineHanzhou, ChinaTaking people
- Nanjing Drum Tower hospitalNanjing, ChinaTaking people
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesTianjin, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Trial code
- NCT06375044
- Record updated
- 28 August 2026
- Original description
This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.Read full original descriptionShow less
A Phase I First-in-human, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0500, A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.
Inclusion: Voluntary participation and signature of informed consent form; ≥18 years of age; Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria who have 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: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy; Participants with known active infection within 14 days prior to the first SIM0500; Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast; Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies/mL or ≥ 2,000 international unit [IU]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial; Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment 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 be included; Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.