BridgeMD
A Phase 2 study of durcabtagene autoleucel, B-cell maturation Antigen (BCMA)-directed CAR-T Cells in adult participants with relapsed and refractory multiple myeloma
EU CTIS ID: 2023-507140-37-00
What this study is testing
Evaluate the efficacy of durcabtagene autoleucel with respect to disease response per independent review committee (IRC)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age at the time of informed consent form (ICF) signature.
- Adult participants with relapsed and refractory multiple myeloma who have received at least 3 prior lines of therapy including an IMiD (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab), and have documented evidence of disease progression (IMWG criteria).
- Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen).
- Measurable disease at enrollment as defined by the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening.
- Must have a leukapheresis material of non-mobilized cells accepted for manufacturing.
You likely can't join if
- Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy.
- Participants who have received prior BCMA-directed bi-specific antibodies or anti-BCMA antibody drug conjugate.
- Known hypersensitivity or contraindication to any product (including its excipients) to be given to the participant as per the study protocol (e.g., durcabtagene autoleucel, tocilizumab and LD agents).
- Prior autologous SCT within 3 months or allogeneic SCT within 6 months prior to signing informed consent.
- Active Graft-versus-Host Disease (GVHD), grade 2-4 according to the Mount Sinai GvHD International Consortium criteria or requiring systemic treatment. Note: Systemic therapy for GvHD must have been discontinued at least 2 weeks prior to durcabtagene autoleucel administration.
- Plasma cell leukemia and other plasmacytoid disorders, non-secretory myeloma without other evidence of measurable disease.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Saudi Arabia
- Singapore
- United States
- Canada
- Australia
- Brazil
- Japan
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Saudi Arabia; Singapore; United States; Canada; Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.