Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)

March 27, 2024 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
        • Contact:
          • Sarah Larson, Site 0028
          • Phone Number: 310-829-5471
      • San Francisco, California, United States, 94143
        • Not yet recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Contact:
          • Tara Gregory, Site 0049
          • Phone Number: 720-754-4800
    • Florida
      • Miami, Florida, United States, 33176
        • Not yet recruiting
        • Local Institution - 0045
        • Contact:
          • Site 0045
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
      • Atlanta, Georgia, United States, 30342
        • Not yet recruiting
        • Local Institution - 0004
        • Contact:
          • Site 0004
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Local Institution - 0005
        • Contact:
          • Site 0005
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • Local Institution - 0056
        • Contact:
          • Site 0056
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • Local Institution - 0016
        • Contact:
          • Site 0016
    • Kentucky
      • Saint Matthews, Kentucky, United States, 40207
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Local Institution - 0010
        • Contact:
          • Site 0010
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Not yet recruiting
        • Local Institution - 0034
        • Contact:
          • Site 0034
    • New York
      • Buffalo, New York, United States, 14263
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Not yet recruiting
        • Local Institution - 0054
        • Contact:
          • Site 0054
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Local Institution - 0032
        • Contact:
          • Site 0032
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Local Institution - 0043
        • Contact:
          • Site 0043
    • Texas
      • Dallas, Texas, United States, 75390-88520
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • Local Institution - 0055
        • Contact:
          • Site 0055
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986393
Biological: BMS-986393
Specified dose on specified days
Other Names:
  • CC-95266,
  • GPRC5D CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall response (BOR)
Time Frame: Up to approximately 5 years
The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT)
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Best overall response (BOR)
Time Frame: Up to approximately 5 years
The number and percent of participants achieving complete response (CR) [including stringent complete response sCR] in quadruple class exposed participants received at least 4 prior lines of therapy (LOT)
Up to approximately 5 years
BOR of partial response (PR) or better
Time Frame: Up to approximately 5 years
The number and percent of participants achieving BOR of PR in quadruple class exposed participants received at least 3 prior LOT
Up to approximately 5 years
BOR of complete response (CR) [including stringent complete response sCR]
Time Frame: Up to approximately 5 years
The number and percent of participants achieving CR (including sCR) in quadruple class exposed participants received at least 3 prior LOT
Up to approximately 5 years
Incidence of adverse events (AEs)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Incidence of serious adverse events (SAEs)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Incidence of adverse event of special interest (AESI)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Incidence of participants with clinical laboratory abnormalities
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Minimal residual disease (MRD) negative status as determined using next generation sequencing (NGS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Duration of response (DOR) assessed by an IRC
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Progression-free survival (PFS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Overall response rate (ORR) assessed by an Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Complete response rate (CRR) assessed by an Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time to response (TTR) assessed by an Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Duration of response (DOR) assessed by an Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Maximum observed plasma concentration (Cmax)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Area under the concentration-time curve (AUC)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2024

Primary Completion (Estimated)

October 2, 2026

Study Completion (Estimated)

June 4, 2030

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA088-1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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