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

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: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: SIM0500

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wenjuan Wang; Email: wangwenjuan4@simceregroup.com
• Study Contact Backup: Name: Study Contact; Phone Number: 8573330740; Email: clinicaltrials@simceregroup.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Beijing Chaoyang Hospital Capital Medical University
      • Contact: Wen Gao
  • 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
  • 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
  • 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
      • Not yet recruiting
      • Dana Farber Cancer institution
      • Contact: Dana Farber Cancer institution
  • 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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Time Frame
Dose-limiting toxicity (DLT)	At the end of Cycle 1 (each cycle is 28 days)

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborators: Shanghai Xianxiang Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Estimated): June 30, 2026
• 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): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma
• 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