QUINTESSENTIAL
Phase 2 Study of BMS-986393, a GPRC5D-directed CART-Cell Therapy, in Participants with Relapsed or Refractory Multiple Myeloma
What will happen during the trial?
This trial is seeking approximately 150 participants. Participants will receive BMS-986393, an investigational, autologous CAR T-cell therapy.
Participants will start the process of receiving BMS-986393 by undergoing a process called leukapheresis. This means that T cells will be removed from their blood and changed in a laboratory to become the investigational CAR T-cell therapy, BMS-986393. During the time that BMS-986393 is being manufactured, participants will receive mandatory bridging therapy.
These investigational BMS-986393 CAR T-cells are then given back by intravenous infusion. Before receiving investigational BMS-986393, participants will receive a conditioning regimen of chemotherapy over three days.
Participants may be hospitalized while receiving BMS-986393 or may receive investigational BMS-986393 at a qualified outpatient center depending on the investigators discretion. Participants will need to be closely monitored after receiving investigational BMS-986393. Patients will need to stay within a 30-minute transportation ride to the study site for at least 7 days and then within 120-minute transportation ride to the site and have a dedicated full-time caregiver or caregivers until 1 month after the investigational BMS-986393 infusion.
[arm1]
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 2
- Enrollment
- 150 patients (estimated)
- Sponsors
- Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb, Juno Therapeutics, a Subsidiary of Celgene
- Collaborators
- Juno Therapeutics, a Subsidiary of Celgene
- Tags
- CAR T Cell, GPRC5D
- Trial Type
- Treatment
- Last Update
- 5 days ago
- SparkCures ID
- 1843
- NCT Identifier
- NCT06297226
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