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.
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.
Fibrinogen ≥ 1.0 g/L;
None
Single group
BR101 injection
Biological/VaccineSingle doses and Multiple doses of BR101 injection will be infused.
Dose-Limiting Toxicity (DLT)
To evaluate the safety, tolerability, and determine therecommended dose of BR101 injection for relapsed/refractory multiple myeloma
Maximum Tolerated Dose (MTD)
MTD is the highest dose for DLT in ≤1/6 subjects
Incidence of abnormalities
Incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs.
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
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
Progression Free Survival (PFS)
The length of time that a participant's disease did not progress during or after BR101 infusion.
Overall survival (OS)
From the start of the clinical trial until death from any cause
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Byterna Therapeutics Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
