Not Yet RecruitingPhase 1

BR101 in Patients With Relapsed/Refractory Multiple Myeloma

China10 participantsStarted 2026-04-30

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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;

What they're measuring

Dose-Limiting Toxicity (DLT)

Timeframe: Up to 28 days

Maximum Tolerated Dose (MTD)

Timeframe: Up to 28 days

Incidence of abnormalities

Timeframe: Up to 28 days

Trial details

NCT IDNCT07537049

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Ning Li, MD,PhD

010-87788713 lining@cicams.ac.cn

View on ClinicalTrials.gov More Multiple Myeloma (MM) trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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;