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NCT Number: NCT06297226

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of multiple myeloma (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, anti-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 2016 criteria.
  • Participants must 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. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
  • 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.

Treatment and study plan

Arlocabtagene Autoleucel

Biological

Specified dose on specified days

Other names: CC-95266,, GPRC5D CAR T cells, BMS-986393, Arlo-cel

Primary outcomes

  1. Cohort 1: Best overall response (BOR) of partial response (PR) or better

    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)

Secondary outcomes

  1. 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

  2. Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)

    Time frame: Up to approximately 5 years

    The number and percent of participants achieving complete response (CR) [including stringent complete response sCR] in participants having received at least 3 prior lines of therapy (LOT)

  3. Minimal residual disease (MRD) negative status

    Time frame: Up to approximately 5 years

  4. 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

  5. Duration of response (DOR) assessed by an IRC

    Time frame: Up to approximately 5 years

    Median DOR for responders only as estimated using Kaplan-Meier method and frequencies of participants who progressed, died, and were censored

  6. Progression-free survival (PFS)

    Time frame: Up to approximately 5 years

  7. Overall survival (OS)

    Time frame: Up to approximately 5 years

  8. Overall response rate (ORR) assessed by an Investigator

    Time frame: Up to approximately 5 years

  9. Complete response rate (CRR) assessed by an Investigator

    Time frame: Up to approximately 5 years

  10. Time to response (TTR) assessed by an Investigator

    Time frame: Up to approximately 5 years

  11. Duration of response (DOR) assessed by an Investigator

    Time frame: Up to approximately 5 years

  12. Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator

    Time frame: Up to approximately 5 years

  13. Maximum observed plasma concentration (Cmax)

    Time frame: Up to approximately 5 years

  14. Area under the concentration-time curve (AUC)

    Time frame: Up to approximately 5 years

  15. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to approximately 5 years

  16. 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

  17. Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up

    Time frame: Up to approximately 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Acronym: QUINTESSENTIAL

Important dates

Study start
2024
Primary completion
2027
Study completion
2032
First posted
Mar 7, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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