Assessing BMS-986453 for treating relapsed multiple myeloma
A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
PHASE1 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT06153251
This study is testing a new treatment called BMS-986453, combined with other medications, to see if it can help people with relapsed multiple myeloma who haven't responded to previous therapies.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 187 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (industry) |
| Locations | 19 sites (Birmingham, Alabama and 18 other locations) |
| Trial ID | NCT06153251 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of BMS-986453 in patients with relapsed and/or refractory multiple myeloma. Participants must have experienced disease progression after previous treatments and have received at least three prior anti-myeloma regimens. The study involves administering BMS-986453 along with Fludarabine and Cyclophosphamide to assess its therapeutic potential. The goal is to determine how well this dual-targeting approach can manage the disease.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with relapsed and/or refractory multiple myeloma who have undergone multiple prior treatments.
Not a fit: Patients with active central nervous system involvement of multiple myeloma or other specific hematological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies using similar dual-targeting approaches have shown promise, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease. * Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry. * Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants must have adequate organ function. Exclusion Criteria: * Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma. * Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis. * Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis. * Other protocol-defined inclusion/exclusion criteria apply.
Where this trial is running
Birmingham, Alabama and 18 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- City of Hope Comprehensive Cancer Center — Duarte, California, United States (RECRUITING)
- UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco, California, United States (RECRUITING)
- Stanford University Medical Center — Stanford, California, United States (RECRUITING)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (RECRUITING)
- Yale Cancer Center — New Haven, Connecticut, United States (RECRUITING)
- Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Local Institution - 0008 — Nashville, Tennessee, United States (NOT_YET_RECRUITING)
- Tennessee Oncology — Nashville, Tennessee, United States (RECRUITING)
- Swedish Medical Center — Seattle, Washington, United States (RECRUITING)
- Hôpital Saint-Louis — Paris, France (RECRUITING)
- Universitaetsklinikum Koeln — Cologne, Germany (RECRUITING)
- Universitaetsklinikum Heidelberg — Heidelberg, Germany (RECRUITING)
- Universitaetsklinikum Wuerzburg — Würzburg, Germany (RECRUITING)
- Clinica Universidad de Navarra — Pamplona, Navarre, Spain (RECRUITING)
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca — Salamanca, Spain (RECRUITING)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsed and/or Refractory Multiple Myeloma, Dual Targeting, BCMAxGPRC5D, GPRC5DxBCMA, BMS-986453, CAR T, CART, Multiple Myeloma