Relapsed or Refractory Multiple MyelomaPhase 1NCT06375044
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing SIM0500 in people with Relapsed or Refractory Multiple Myeloma, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 16 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- SIM0500
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 24 May 2024to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Toxicities from previous anticancer therapies should have resolved to baseline levels 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 ≥ 2,000 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.
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of 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.
- 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.
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Participants with known active infection within 14 days prior to the first SIM0500.
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
Dana Farber Cancer institution
Boston, Massachusetts, 02215
Shonali Midha, 855-776-0015, clinicaltrials@simceregroup.com
- Recruiting
University of North Carolina Hospitals at Hillsborough
Hillsborough, North Carolina, 27278
Eben Lichtman, MD
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015
Sikander Ailawadhi, MD
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Jesus Berdeja, MD
- Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
NYU
- Recruiting
Icahn School of Medicine at Mount Sinai，The Tisch Cancer Institute
New York, New York, 10029
Mt. Sinai
- Recruiting
UC Irvine Health
Orange, California, 92868
Polina Bellman, MD
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015
Saurabh Chhabra, MD
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015
Shaji Kumar, MD
China7 sites, 7 recruiting
- Recruiting
Beijing Chaoyang Hospital Capital Medical University
Beijing, Beijing Municipality, 100000
Wen Gao
- Recruiting
The First Affiliated Hospital of FuJian Medical University
Fuzhou, Fujian, 350005
Clinical Trials Referral Office, 8573330740, clinicaltrials@simceregroup.com
Zhiyong Zeng
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Zhongjun Xia
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310000
Zhen Cai
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Clinical Trials Referral Office, 8573330740, clinicaltrials@simceregroup.com
Bing Chen
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
Yan Xu
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Baijun Fang
About this study
Official title: 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.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- SIM0500
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0500Drug
Participants will receive SIM0500 in a 28-day cycle until disease progression, intolerable toxicity, or until the participant voluntarily withdraws from trial intervention, or end of study, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| SIM0500 | Experimental | Not described Receives: Drug: SIM0500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Dose-limiting toxicity (DLT)
DLTs are defined as specific non-hematologic toxicity, or hematologic toxicity
Measured: From enrollment up to 35 days afterward
Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from grade 1 to Grade 5.
Measured: From enrollment up to 24 months afterward
Secondary outcomes (2)
Pharmacokinetics (PK) of SIM0500
Serum samples will be analyzed to determine concentrations of SIM0500
Measured: From enrollment up to 24 months afterward
Immunogenicity of SIM0500
Number of participants with presence of anti-drug antibodies to SIM0500 will be reported
Measured: From enrollment up to 24 months afterward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start24 May 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianxiang Medical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375044
- Sponsor's protocol ID
- SIM0500-101
- Status last verified
- Feb 2026
- First submitted
- 16 Apr 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06375044
- Acronym / sponsor ID
- SIM0500-101
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianxiang Medical Technology Co., Ltd.
- Study start
- 24 May 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIM0500 | Experimental | Drug: SIM0500 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Toxicities from previous anticancer therapies should have resolved to baseline levels 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 ≥ 2,000 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.
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIM0500Participants will receive SIM0500 in a 28-day cycle until disease progression, intolerable toxicity, or until the participant voluntarily withdraws from trial intervention, or end of study, whichever comes first. | Drug | SIM0500 |
Primary outcome
Part 1: Number of Participants with Dose-limiting toxicity (DLT)
Time frame: From enrollment up to 35 days afterward
DLTs are defined as specific non-hematologic toxicity, or hematologic toxicity
Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
Time frame: From enrollment up to 24 months afterward
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from grade 1 to Grade 5.
2 secondary outcomes
Pharmacokinetics (PK) of SIM0500
Time frame: From enrollment up to 24 months afterward
Immunogenicity of SIM0500
Time frame: From enrollment up to 24 months afterward
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM0500 in people with Relapsed or Refractory Multiple Myeloma, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (8573330740, clinicaltrials@simceregroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants with Dose-limiting toxicity (DLT) (time frame: From enrollment up to 35 days afterward). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.