Evaluating SIM0500 for patients with relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter phase 1 clinical trial aims to assess the safety, tolerability, efficacy, and pharmacokinetics of SIM0500 in adults diagnosed with relapsed or refractory multiple myeloma. The trial consists of two parts: a dose escalation phase and a dose optimization phase, where participants will receive SIM0500 until disease progression, intolerable toxicity, withdrawal of consent, or the end of the trial. Participants must meet specific eligibility criteria, including having failed all standard treatments for their condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• UC Irvine Health
  Orange, California, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Dana Farber Cancer institution
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic Rochester
  Rochester, Minnesota, United States Recruiting
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: clinicaltrials@simceregroup.com
• Phone: 8573330740

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AZD4045 in Relapsed or Refractory Multiple Myeloma

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• mRNA-2808 for relapsed or refractory multiple myeloma

  This will test whether mRNA-2808 is safe and tolerable for people with relapsed or refractory multiple myeloma who have already received standard therapies.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.