Actively Recruiting
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2026-03-06
130
Participants Needed
11
Research Sites
240 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead Sponsor
S
Shanghai Xianxiang Medical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma according to IMWG criteria and failed all standard treatments
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Adequate blood, liver, and kidney function
You will not qualify if you...
- Toxicities from previous cancer treatments resolved to baseline or Grade 1 or less, except alopecia or peripheral neuropathy
- Active hepatitis B or C infection; antiviral treatment required if hepatitis B positive
- Known HIV infection or AIDS
- Pregnant, breastfeeding, or planning to conceive or father children during the trial
- Active autoimmune disease, except certain controlled conditions like vitiligo or psoriasis not requiring systemic treatment
- Current or previous other cancers within 3 years, except certain skin, bladder, prostate, cervix, or breast cancers
- Active central nervous system involvement or signs of meningeal multiple myeloma
- Active infections within 14 days before starting SIM0500
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Dana Farber Cancer institution
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
4
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
6
Icahn School of Medicine at Mount Sinai，The Tisch Cancer Institute
New York, New York, United States, 10029
Actively Recruiting
7
Beijing Chaoyang Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
8
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
9
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
10
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
11
The First Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
S
Study Contact
CONTACT
W
Wenjuan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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