Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma

August 27, 2026 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Recruiting
        • Beijing Chaoyang Hospital Capital Medical University
        • Contact:
          • Wen Gao
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Principal Investigator:
          • Zhiyong Zeng
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Zhongjun Xia
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Baijun Fang
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Principal Investigator:
          • Bing Chen
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Yan Xu
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310000
        • Recruiting
        • the First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Zhen Cai
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
        • Principal Investigator:
          • Saurabh Chhabra, MD
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health
        • Principal Investigator:
          • Polina Bellman, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Principal Investigator:
          • Sikander Ailawadhi, MD
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Principal Investigator:
          • Shaji Kumar, MD
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
        • Contact:
          • NYU
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai，The Tisch Cancer Institute
        • Contact:
          • Mt. Sinai
    • North Carolina
      • Hillsborough, North Carolina, United States, 27278
        • Recruiting
        • University of North Carolina Hospitals at Hillsborough
        • Principal Investigator:
          • Eben Lichtman, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
        • Principal Investigator:
          • Jesus Berdeja, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntary participation and signature of informed consent form.
  2. ≥18 years of age.
  3. 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.
  4. Life expectancy ≥12 weeks.
  5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  6. Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

  1. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
  2. 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.
  3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  5. 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.
  6. 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.
  7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  8. Participants with known active infection within 14 days prior to the first SIM0500.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SIM0500
Drug: SIM0500
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment up to 35 days afterward
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.
From enrollment up to 24 months afterward

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of SIM0500
Time Frame: From enrollment up to 24 months afterward
Serum samples will be analyzed to determine concentrations of SIM0500
From enrollment up to 24 months afterward
Immunogenicity of SIM0500
Time Frame: From enrollment up to 24 months afterward
Number of participants with presence of anti-drug antibodies to SIM0500 will be reported
From enrollment up to 24 months afterward

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

Shanghai Xianxiang Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM0500-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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