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

Relapsed and/or Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153251
• Other study ID #: CA119-0002
• Status: Recruiting
• Phase: Phase 1
• Start date: January 23, 2024
• Est. completion date: November 29, 2027

Study information

• Verified date: May 2024
• Source: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
• Contact: BMS Study Connect www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: November 29, 2027
• Est. primary completion date: November 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed and/or Refractory Multiple Myeloma

Intervention

Drug:
• BMS-986453
Specified dose on specified days
• Fludarabine
Specified dose on specified days
• Cyclophosphamide
Specified dose on specified days

Locations

Country	Name	City	State
France	Local Institution - 0019	Paris
Germany	Local Institution - 0021	Heidelberg
Germany	Local Institution - 0017	Köln
Germany	Local Institution - 0018	Wuerzburg
Spain	Local Institution - 0015	Pamplona	Navarra
Spain	Local Institution - 0014	Salamanca
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	Local Institution - 0003	Duarte	California
United States	Local Institution - 0008	Nashville	Tennessee
United States	Local Institution - 0020	Nashville	Tennessee
United States	Local Institution - 0005	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Local Institution - 0011	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Local Institution - 0006	Stanford	California
United States	Local Institution - 0016	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events (AEs)		Up to 2 years
Primary	Number of participants with serious adverse events (SAEs)		Up to 2 years
Primary	Number of participants with AEs leading to discontinuation		Up to 2 years
Primary	Number of participants with AEs leading to death		Up to 2 years
Primary	Number of participants with dose-limiting toxicities (DLTs)		Up to 2 years
Secondary	Maximum observed concentration (Cmax)		Up to 2 years
Secondary	Time of maximum observed concentration (Tmax)		Up to 2 years
Secondary	Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))		Up to 2 years
Secondary	Overall response rate (ORR)		Up to 2 years
Secondary	Complete response rate (CRR)		Up to 2 years
Secondary	Number of participants with very good partial response (VGPR) or better		Up to 2 years
Secondary	Progression-free survival (PFS)		Up to 2 years
Secondary	Overall survival (OS)		Up to 2 years
Secondary	Time to response (TTR)		Up to 2 years
Secondary	Time to complete response (TTCR)		Up to 2 years
Secondary	Duration of response (DOR)		Up to 2 years
Secondary	Duration of complete response (DOCR)		Up to 2 years
Secondary	Persistence of BMS-986453 in peripheral blood	Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)	Up to 2 years
Secondary	Expansion rate	Defined as Cmax divided by Tmax	Up to 2 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting