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NCT06153251 | RECRUITING | Relapsed and/or Refractory Multiple Myeloma

A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
Sponsor:

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Brief Summary:

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

Condition or disease

Relapsed and/or Refractory Multiple Myeloma

Intervention/treatment

BMS-986453

Fludarabine

Cyclophosphamide

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-01-23
Estimated Primary Completion Date : 2027-11-29
Estimated Study Completion Date : 2027-11-29

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 must have received at least 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and 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
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

Location Details

NCT06153251

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35294

RECRUITING

United States, California

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

RECRUITING

United States, California

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, United States, 94143

RECRUITING

United States, California

Stanford University Medical Center

Stanford, California, United States, 94305

RECRUITING

United States, Colorado

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

RECRUITING

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06520

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

NOT YET RECRUITING

United States, Tennessee

Local Institution - 0008

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Tennessee

Tennessee Oncology

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Washington

Swedish Medical Center

Seattle, Washington, United States, 98104

RECRUITING

France,

Saint-Louis Hospital

Paris, France, 75010

RECRUITING

Germany,

Universitaetsklinikum Heidelberg

Heidelberg, Germany, D-69120

RECRUITING

Germany,

University Clinic Koeln

Köln, Germany, 50937

RECRUITING

Germany,

Universitaetsklinikum Wuerzburg

Wuerzburg, Germany, 97080

RECRUITING

Spain, Navarra

Clinic University of Navarra

Pamplona, Navarra, Spain, 31008

RECRUITING

Spain,

Salamanca University Hospital - Salamanca University Assistance Complex

Salamanca, Spain, 37007