Full Title:

A Phase 2, Open-Label, Multicenter Study of BMS-986393, a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)

Myeloma stage or condition:

Multiple Myeloma

Study phase:

Phase 2

Summary/Purpose:

The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.

Detailed Description:

Not available

Treatments:

Biological : BMS-986393

Specified dose on specified days

Study Arms:

Experimental : BMS-986393

Study Type:

Interventional

Study Design:

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Recruitment status:

Recruiting

Eligibility criteria:

sion Criteria

Documented diagnosis of multiple Mmyeloma (MM) as per International Myeloma Working Group (IMWG) criteria.

Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and anti-B cell maturation antigen (BCMA) therapy], and at least 3 prior lines of therapy (LOT).

Documented disease progression during or after their last anti-myeloma regimen as per IMWG.

Participants must have measurable disease during screening.

Have measurable disease during screening.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria

Active or history of central nervous system involvement with MM.

Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis.

Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.

Other protocol-defined Inclusion/Exclusion criteria apply.

Locations / Centres:

Local Institution - 0020, Calgary, Alberta – Not yet recruiting

Local Institution - 0021, Montréal, Quebec – Not yet recruiting

Contacts:

Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]

Publications:

???

First posted:

2024-03-07

Actual start date:

March 21, 2024

Last updated:

2024-05-09

Estimated enrollment:

150

Estimated completion date:

2030-06-04

Estimated primary completion date:

2026-10-02

Condition:

Multiple Myeloma

Gender:

All

Ages:

18 Years-N/A

Accepts healthy volunteers:

No

Listed location countries:

Canada

United States

NCT number:

NCT06297226

Other study ID numbers:

CA088-1000

Has Data monitoring committee:

Yes

U.S. FDA-regulated product:

Yes

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

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

Collaborators:

???

Investigators:

Bristol-Myers Squibb Bristol-Myers Squibb

Protocol Registration and Results System:

???

Verification date:

2024-05-01