Universal CAR-T Cell Therapy for MM
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioray Laboratories
About this trial
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Expected survival of at least 3 months;
Subjects should have measurable disease that meets the IMWG 2016 criteria;
Previously received at least two lines of prior anti-myeloma therapy ；
Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ；
Disqualifiers
Pregnant or breastfeeding women;
History of other malignant tumors;
Active autoimmune diseases requiring immunotherapy;
Previously received allogeneic stem cell transplantation;
Trial design
Design model
Single group
Treatments tested in this trial
Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection
DrugThe study drug is administered intravenously at a fixed dose within 1-2 days after lymphocyte depletion, and its efficacy and safety are observed.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT
The number and severity of dose-limiting toxicity (DLT) events
Time frame
Within 28 Days After BRL-305 Infusion2
AEs
The total number, incidence, and severity of AEs
Time frame
Up to 24 Months After BRL-305 InfusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bioray Laboratories
Lead sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
Source ClinicalTrials.gov