🏛️ Verified NIH Record • Updated 2026-08-27

Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma (NCT06375044)

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

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Arizona — Phoenix, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (16 Sites)

  • Mayo Clinic Arizona — Phoenix, Arizona
  • UC Irvine Health — Orange, California
  • Mayo Clinic Florida — Jacksonville, Florida
  • Dana Farber Cancer institution — Boston, Massachusetts
  • Mayo Clinic Rochester — Rochester, Minnesota
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
  • Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute — New York, New York
  • University of North Carolina Hospitals at Hillsborough — Hillsborough, North Carolina
  • Tennessee Oncology — Nashville, Tennessee
  • Beijing Chaoyang Hospital Capital Medical University — Beijing, Beijing Municipality
  • The First Affiliated Hospital of FuJian Medical University — Fuzhou, Fujian
  • Sun Yat-sen University Cancer Center — Guangzhou, Guangdong
  • Henan Cancer Hospital — Zhengzhou, Henan
  • Nanjing Drum Tower Hospital — Nanjing, Jiangsu
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality
  • The First Affiliated Hospital Zhejiang University School of Medicine — Hanzhou, Zhejiang

📞 Contact the Study Coordinator

Phone: (857) 333-0740

Email: clinicaltrials@simceregroup.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗