Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
Public ClinicalTrials.gov record NCT06375044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06375044
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 23, 2024
- Primary completion
- Sep 29, 2027
- Completion
- Dec 29, 2028
- Last update posted
- Aug 27, 2026
2024 – 2028
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | Recruiting |
| UC Irvine Health | Orange | California | 92868 | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Recruiting |
| Dana Farber Cancer institution | Boston | Massachusetts | 02215 | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | Recruiting |
| Icahn School of Medicine at Mount Sinai，The Tisch Cancer Institute | New York | New York | 10029 | Recruiting |
| University of North Carolina Hospitals at Hillsborough | Hillsborough | North Carolina | 27278 | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | 37203 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06375044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06375044 live on ClinicalTrials.gov.