BR101 in Patients With Relapsed/Refractory Multiple Myeloma

NCT07537049 | Not Yet Recruiting Phase 1

• 1 other identifier: BR101-MM001/IIT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma (MM)

Outcome Measures

Primary Outcomes (3)

• Dose-Limiting Toxicity (DLT)

  To evaluate the safety, tolerability, and determine therecommended dose of BR101 injection for relapsed/refractory multiple myeloma

  Up to 28 days

• Maximum Tolerated Dose (MTD)

  MTD is the highest dose for DLT in ≤1/6 subjects

  Up to 28 days

• Incidence of abnormalities

  Incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs.

  Up to 28 days

Secondary Outcomes (9)

• Overall Response Rate (ORR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Progression Free Survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 15 years

• MRD-negative rate

  Up to 2 years

Study Arms (1)

BR101 injection

EXPERIMENTAL

In vivo BCMA/CD19 bi-specific Chimeric Antigen Receptor (CAR) T Cell Therapy

Biological: BR101 injection

Interventions

BR101 injection BIOLOGICAL

Single doses and Multiple doses of BR101 injection will be infused.

BR101 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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:

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Byterna Therapeutics Ltd.: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Ning Li, MD,PhD

CONTACT

010-87788713; lining@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)