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Multiple Myeloma (MM)Phase 1NCT07537049

BR101 in Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1 study testing BR101 injection in people with Multiple Myeloma (MM), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Myeloma (MM)
What is being tested?
BR101 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
30 Apr 2026to 30 Apr 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 1) Coagulation function:
  • Fibrinogen ≥ 1.0 g/L;
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  • 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.
  • 3) Renal function:
  • Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula, see Appendix 16.3).
  • 4) 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).
  • 6. Meet the following criteria for multiple myeloma (MM):
  • Subjects with a confirmed diagnosis of multiple myeloma according to the IMWG updated criteria (2016);
  • BCMA expression positive on the plasma cell membrane surface detected by immunohistochemistry (IHC) or flow cytometry in the subject's tumor specimen (bone marrow);
  • Meet one of the following laboratory criteria:
  • Serum M-protein: IgG-type M-protein ≥ 5 g/L; or IgA-type M-protein ≥ 5 g/L; or IgD-type M-protein above the normal reference range;
  • Urinary M-protein ≥ 200 mg/24 h;
  • Serum free light chain ≥ 100 mg/L with an abnormal serum κ/λ free light chain ratio;
  • If the patient has peripheral plasma cells, a plasma cell proportion < 5% is eligible for enrollment.
  • Relapsed/refractory multiple myeloma, defined as meeting one or more of the following:
  • Received at least 3 lines of prior therapy (including chemotherapy regimens based on proteasome inhibitors and immunomodulatory drugs);
  • Documented disease progression during or within 12 months after the most recent anti-multiple myeloma therapy.

Who cannot join

  • 1. 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.
  • 2. 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.
  • 3. 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).
  • 4. 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.
  • 5. Patients with suspected or documented central nervous system involvement by plasma cell neoplasm during screening.
  • 6. 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.
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  • 7. Unstable systemic diseases judged by the investigator, including but not limited to severe hepatic, renal, or metabolic diseases requiring pharmacologic management.
  • 8. 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.
  • 9. 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.
  • 10. 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.
  • 11. 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.
  • 12. Prior treatment with in vivo or ex vivo CAR-T therapy or other genetically modified cell therapy prior to enrollment.
  • 13. Prior BCMA-targeted therapy administered more than 3 years before enrollment, unless BCMA expression >30%.
  • 14. Administration of a live attenuated vaccine within 1 month prior to study drug dosing.
  • 15. Prior receipt of any of the following anti-tumor therapies:
  • 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.
  • 16. Known severe hypersensitivity to tocilizumab, BR101 Injection, or any of its excipients.
  • 17. Any other conditions that, in the investigator's judgment, render the subject ineligible for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ning Li, MD,PhD contact

010-87788713

lining@cicams.ac.cn

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing

    Ning Li, MD, PhD, 010-87788713, lining@cicams.ac.cn

Other trials in China

About this study

Official title: An Open-Label, Single-Arm Clinical Study Evaluating the Safety and Efficacy of BR101 Injection in Patients With Relapsed/Refractory Multiple Myeloma

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.

Read the detailed description

This study is a single-center, open-label, single-arm, phase 1 clinical trial consisting of a dose-escalation phase followed by a dose-expansion phase.The primary objectives are to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and to characterize the safety and tolerability profile of BR101 injection in subjects with relapsed or refractory multiple myeloma.Secondary objectives include evaluating the pharmacokinetic (PK) characteristics of BR101 after intravenous administration and exploring the preliminary anti-tumor efficacy of the investigational product in this patient population.Throughout the study, adverse events, vital signs, laboratory parameters, and disease status will be closely monitored to comprehensively assess the safety, pharmacokinetics, and preliminary clinical activity of BR101.

Being tested
BR101 injection
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BR101 injectionBiological

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

Study groups in NCT07537049
Study groupRoleWhat they receive
BR101 injectionExperimentalIn vivo BCMA/CD19 bi-specific Chimeric Antigen Receptor (CAR) T Cell Therapy
Receives: Biological: BR101 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT)

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

    Measured: Up to 28 days

  2. Maximum Tolerated Dose (MTD)

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

    Measured: Up to 28 days

  3. Incidence of abnormalities

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

    Measured: Up to 28 days

Secondary outcomes (9)

  1. Overall Response Rate (ORR)

    The proportion of subjects assessed by the investigator as having achieved complete remission (CR) or partial remission (PR) following administration of BR101 injection

    Measured: Up to 2 years

  2. Duration of Response (DOR)

    The time from the start of the first assessment of CR or PR to the first assessment as disease recurrence or progression or death

    Measured: Up to 2 years

  3. Progression Free Survival (PFS)

    The length of time that a participant's disease did not progress during or after BR101 infusion.

    Measured: Up to 2 years

  4. Overall survival (OS)

    From the start of the clinical trial until death from any cause

    Measured: Up to 15 years

  5. MRD-negative rate

    The proportion of subjects who tested negative for MRD in the bone marrow by flow cytometry following infusion with BR101 injection.

    Measured: Up to 2 years

  6. Pharmacokinetics (PK) indicator (Cmax)

    The peak concentration of CAR+ cells or circular mRNA amplified in the peripheral blood (Cmax, detected by qPCR or Flow Cytometry).

    Measured: Up to 90 days

  7. Pharmacokinetics (PK) indicator (AUC)

    CAR+ cells or circular mRNA blood concentrations will be measured at different time points to evaluate the area under the curve (AUC). (AUC, detected by qPCR or Flow Cytometry).

    Measured: Up to 90 days

  8. Pharmacokinetics (PK) indicator (Tmax)

    CAR+ cells or circular mRNA blood concentrations will be measured at different time points to evaluate the peak plasma time (Tmax). Tmax is defined as the time to reach the highest concentration (Tmax, detected by qPCR or Flow Cytometry).

    Measured: Up to 90 days

  9. Pharmacokinetics (PK) indicator (T1/2)

    CAR+ cells or circular mRNA blood concentrations will be measured at different time points to evaluate the elimination half-life in hours (T1/2). T1/2 is defined as the time point when the concentration of CAR+ cells or circular mRNA reaches half of maximum in a patient's peripheral blood (T1/2, detected by qPCR and Flow Cytometry).

    Measured: Up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07537049
Sponsor's protocol ID
BR101-MM001/IIT
Status last verified
Mar 2026
First submitted
12 Apr 2026
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BR101 injection in people with Multiple Myeloma (MM), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ning Li, MD,PhD (010-87788713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07537049.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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