NCT07537049
BR101 in Patients With Relapsed/Refractory Multiple Myeloma
Not Yet Recruiting · Phase 1 · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · registry updated 2026-04-17
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This study is an open-label, single-arm, dose-escalation and dose-expansion clinical trial designed to evaluate the maximum tolerated dose, safety, pharmacokinetic profile following administration of BR101 injection, and preliminary efficacy in subjects with relapsed or refractory multiple myeloma.
Inclusion
- Voluntarily sign the informed consent form and be expected to complete follow-up examinations and treatments as required by the study procedures.
- Aged 18 to 75 years (inclusive), with no gender restriction.
- ECOG performance status of 0 or 1, and expected survival time ≥ 12 weeks.
- Adequate organ function, with laboratory test results within the following criteria within 7 days prior to enrollment:
- \) Coagulation function:
- Fibrinogen ≥ 1.0 g/L;
Exclusion
- \. History of malignancy within the past 5 years, excluding adequately treated non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma), carcinoma in situ of the cervix, or thyroid cancer after radical resection.
- \. Patients who have used or require long-term use of immunosuppressive agents (e.g., cyclosporine or systemic corticosteroids) within 2 weeks prior to enrollment; however, physiological replacement, intermittent, topical, and inhaled corticosteroids are permitted.
- \. Major surgery performed within 2 weeks prior to enrollment, or surgery planned within 2 weeks after study treatment initiation (excluding subjects scheduled for local anesthesia-only procedures).
- \. Subjects with current or past central nervous system (CNS) disorders, such as epilepsy, paralysis, aphasia, stroke, subarachnoid hemorrhage or other CNS hemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- \. Patients with suspected or documented central nervous system involvement by plasma cell neoplasm during screening.
- \. Severe cardiac disease including, but not limited to, unstable angina pectoris, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] class ≥ II), or severe cardiac arrhythmia.