Evaluating SHR-9539 for treating 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 multicenter, open-label Phase I trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SHR-9539 injection in patients diagnosed with multiple myeloma. The study will involve a dose-escalation and dose-expansion approach to determine the optimal dosage and its effects on the disease. Participants will be monitored closely to evaluate their response to the treatment and any potential side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years on day of signing the Informed Consent Form;
2. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
3. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria ；
4. Have a life expectancy of at least 3 months；
5. Male and female subjects with fertility must agree to use efficient contraceptive measures with their partners within 3 months after the last administration of the test drug from the time of signing the informed consent form, and have no fertility plan and avoid donating sperm / eggs. The pregnancy test during the screening period must be negative.

Exclusion Criteria:

1. Central nervous system (CNS) involvement of MM；
2. Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome;
3. Prior Grade 3 or higher CRS (Per ASTCT standards) related to any T cell redirection (eg, CD-3 redirection technology or CAR-T cell therapy).
4. Have other factors that may force the termination of the study, e.g., non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory abnormalities, associated family or social factors, which would affect the safety of the subjects or the collection of data and samples, as determined by the investigator.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Yang Wu
• Email: yang.wu.yw96@hengrui.com
• Phone: 0518-82342973

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

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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.