BR101 in Patients With Relapsed/Refractory Multiple Myeloma

Starting soon · Phase 1

Conditions studied: Multiple Myeloma (MM)

In brief

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.

Key facts

Study ID

NCT07537049

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

10

Starts

2026-04-30

Expected to finish

2029-04-30

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal (ULN);
• Prothrombin time (PT) ≤ 1.5 × ULN. 2) Hepatic function:
• Aspartate aminotransferase (AST) ≤ 2.5 × ULN;
• Alanine aminotransferase (ALT) ≤ 2.5 × ULN;
• Serum total bilirubin ≤ 1.5 × ULN, unless the subject has a documented diagnosis of Gilbert's syndrome;
• Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN may be enrolled.
• Renal function:
• Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula, see Appendix 16.3).
• Hematopoietic function:
• Hemoglobin ≥ 60 g/L (no red blood cell [RBC] transfusion within 7 days prior to laboratory testing; use of recombinant human erythropoietin is permitted); Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L (prior growth factor support is allowed, but no such supportive therapy within 7 days prior to laboratory testing);
• Platelet count ≥ 50 × 10⁹/L (no transfusion support within 7 days prior to laboratory testing);
• Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L;
• T-cell count ≥ 0.15 × 10⁹/L. 5) Cardiopulmonary function:
• Left ventricular ejection fraction (LVEF) ≥ 45%;
• Blood oxygen saturation ≥ 91%. 5. Female subjects of childbearing potential must have a negative pregnancy test during the screening period. All male and female subjects with reproductive potential must agree to use effective contraceptive methods from the signing of the informed consent form until at least 6 months after the completion of BR101 injection infusion, or until CAR-positive cells are undetectable by two consecutive flow cytometry assessments (whichever occurs later). Female subjects considered non-fertile (meeting at least one of the following criteria):
• Status post hysterectomy or bilateral oophorectomy;
• Medically confirmed ovarian failure;
• Medically confirmed postmenopausal status (amenorrhea for at least 12 consecutive months in the absence of pathological or physiological causes).
• Meet the following criteria for multiple myeloma (MM):

You may not qualify if…

• 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.
• Unstable systemic diseases judged by the investigator, including but not limited to severe hepatic, renal, or metabolic diseases requiring pharmacologic management.
• Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the lower limit of detection; positive hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; positive syphilis test.
• Subjects with uncontrolled active fungal, viral, bacterial, or other infections (persistent infection-related signs/symptoms without improvement following appropriate antimicrobial therapy) or infections requiring intravenous antimicrobial therapy.
• Non-hematologic toxicities from prior therapy that have not resolved to baseline or grade ≤ 1 per NCI-CTCAE version 5.0, excluding alopecia and grade 2 peripheral neuropathy.
• Patients who received autologous hematopoietic stem cell transplantation within 12 weeks prior to study drug administration, or who have a history of allogeneic hematopoietic stem cell transplantation.
• Prior treatment with in vivo or ex vivo CAR-T therapy or other genetically modified cell therapy prior to enrollment.
• Prior BCMA-targeted therapy administered more than 3 years before enrollment, unless BCMA expression >30%.
• Administration of a live attenuated vaccine within 1 month prior to study drug dosing.
• Prior receipt of any of the following anti-tumor therapies:
• a) Immune/non-immune targeted systemic therapy within 7 days; b) Cytotoxic therapy within 7 days; c) Proteasome inhibitor and immunomodulatory agent therapy within 2 weeks; d) Radiation therapy within 4 weeks (excluding local radiation to myeloma-related bone lesions); e) Targeted therapy, epigenetic therapy, other investigational medicinal products, or therapy involving invasive investigational medical devices within 5 half-lives.
• Known severe hypersensitivity to tocilizumab, BR101 Injection, or any of its excipients.
• Any other conditions that, in the investigator's judgment, render the subject ineligible for enrollment.

Where it is running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China

Full record on ClinicalTrials.gov

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