Clinical trial NCT06153251: A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed and/or Refractory Multiple Myeloma
Keywords: Dual Targeting
BCMAxGPRC5D
GPRC5DxBCMA
BMS-986453
CAR T
CART
Multiple Myeloma
Relapsed and/or Refractory
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (AEs)
timeFrame: Up to 2 years
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 2 years
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 2 years
measure: Number of participants with AEs leading to death
timeFrame: Up to 2 years
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 2 years
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 2 years
measure: Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
timeFrame: Up to 2 years
measure: Overall response rate (ORR)
timeFrame: Up to 2 years
measure: Complete response rate (CRR)
timeFrame: Up to 2 years
measure: Number of participants with very good partial response (VGPR) or better
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
measure: Time to response (TTR)
timeFrame: Up to 2 years
measure: Time to complete response (TTCR)
timeFrame: Up to 2 years
measure: Duration of response (DOR)
timeFrame: Up to 2 years
measure: Duration of complete response (DOCR)
timeFrame: Up to 2 years
measure: Persistence of BMS-986453 in peripheral blood
timeFrame: Up to 2 years
measure: Expansion rate
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Medical Center at Parnassus Heights
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Local Institution - 0008
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: