NCT06121843 A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
| NCT ID | NCT06121843 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 187 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 187 participants in total. It began in 2024-02-22 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
Eligibility Criteria
Inclusion Criteria: * History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E). * Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG). * Eastern Cooperative Oncology Group performance status of 0-1. * Adherence to contraception requirements. Exclusion Criteria: * Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D). * Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2). * Other protocol-defined inclusion/exclusion criteria apply.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06121843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06121843 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06121843 currently recruiting?
Yes, NCT06121843 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06121843 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Duarte, United States, Jacksonville, United States and 11 additional locations.
Who is sponsoring the NCT06121843 clinical trial?
NCT06121843 is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 187 participants.