Evaluating SHR-9539 for treating multiple myeloma
An Open-label, Multi-center Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of SHR-9539 Injection in Patients With Multiple Myeloma
This study is testing a new injection called SHR-9539 to see if it can safely help people with multiple myeloma feel better and manage their disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06484777 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a documented diagnosis of multiple myeloma and a performance status of 0 or 1.
Not a fit: Patients with central nervous system involvement of multiple myeloma or other specified hematological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with multiple myeloma.
How similar studies have performed: While this approach is part of ongoing research in multiple myeloma, the specific treatment SHR-9539 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chengdu, Sichuan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.