> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-effectiveness-and-tolerable-bf2618cc-f052-43c0-a005-bd672213d933 > Record changed: 2026-10-13 # 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 NCT06121843 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) Participants 187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) Lead sponsor Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) Start date 2024-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) Number of sites 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Official title** A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Dates **Completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **First posted** 2023-11-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Registry last updated** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Primary completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Start date** 2024-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Size and sites **Participants** 187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Planned participants** 187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Number of sites** 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Lead sponsor** Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Identifiers **Registry ID** NCT06121843 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **ClinicalTrials.gov ID** NCT06121843 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Outcomes ### Primary outcomes 1. Incidence of adverse events (AEs) Timeframe: Up to 2 years 2. Incidence of serious adverse events (SAEs) Timeframe: Up to 2 years 3. Incidence of adverse events of special interest (AESI) Timeframe: Up to 2 years 4. Incidence of AEs leading to discontinuation Timeframe: Up to 2 years 5. Number of Deaths Timeframe: Up to 2 years 6. Establish recommended Phase 2 dose (RP2D) Timeframe: Up to 2 years ### Secondary outcomes 1. Overall response rate (ORR) Timeframe: Up to 2 years 2. Complete response rate (CRR) Timeframe: Up to 2 years 3. Very good partial response rate (VGPRR) Timeframe: Up to 2 years 4. Maximum observed concentration (Cmax) of arlocabtagene autoleucel Timeframe: Up to 2 years 5. Time of maximum observed concentration (tmax) of arlocabtagene autoleucel Timeframe: Up to 2 years 6. Area under the concentration-time curve from time 0 to 28 days \[AUC (0-28D)\] of arlocabtagene autoleucel Timeframe: Up to 2 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Sites - University of Alabama at BirminghamBirmingham, United StatesRecruiting - Mayo Clinic in Arizona - PhoenixPhoenix, United StatesRecruiting - City of Hope Comprehensive Cancer CenterDuarte, United StatesRecruiting - Mayo Clinic in FloridaJacksonville, United StatesRecruiting - Northside HospitalAtlanta, United StatesRecruiting - Beth Israel Deaconess Medical CenterBoston, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Mayo Clinic in Rochester, MinnesotaRochester, United StatesRecruiting - University Of Nebraska Medical CenterOmaha, United StatesRecruiting - John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesRecruiting - Roswell Park Cancer InstituteBuffalo, United StatesRecruiting - Laura and Isaac Perlmutter Cancer CenterNew York, United StatesRecruiting - Local Institution - 0009New York, United StatesCompleted - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Local Institution - 0023Pittsburgh, United StatesWithdrawn - Tennessee OncologyNashville, United StatesRecruiting - University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - Arthur J.E. Child Comprehensive Cancer CentreCalgary, CanadaRecruiting - Princess Margaret Cancer CentreToronto, CanadaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06121843.html) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06121843) ## Related records ### Drugs (6) - [Alnuctamab](https://trialight.com/data/asset/alnuctamab-4489c89d-75f0-45e1-a898-dacda22f155a.md) - [Arlocabtagene autoleucel](https://trialight.com/data/asset/arlocabtagene-autoleucel-44aa0454-a3af-4dbc-89e9-90cd45f9c3cf.md) - [Dexamethasone](https://trialight.com/data/asset/dexamethasone-b923ddae-f095-408c-96e9-975238a429ad.md) - [Elranatamab](https://trialight.com/data/asset/elranatamab-43094116-a114-45cf-88c8-60ef9865def2.md) - [Iberdomide hydrochloride](https://trialight.com/data/asset/iberdomide-hydrochloride-120a5099-dbdd-413c-90f7-fb70379af894.md) - [Mezigdomide](https://trialight.com/data/asset/mezigdomide-a5f4e0d3-235e-444c-aca1-0c8eecbc5992.md) ### Lead sponsors (1) - [Juno Therapeutics, Inc., a Bristol-Myers Squibb Company](https://trialight.com/data/company/juno-therapeutics-inc-a-bristol-myers-squibb-company-1b803ec4-d393-4e21-9959-508dc18f3897.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (5) - [CD3D](https://trialight.com/data/target/cd3d-6bee5ce0-96ac-5607-815b-7dbf809d2a64.md) - [CD3E](https://trialight.com/data/target/cd3e-b4b887fd-970b-55c2-bf21-d8b729fecbe7.md) - [CD3G](https://trialight.com/data/target/cd3g-45960ced-28d6-5e39-be86-e6477c0df8f8.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [TNFRSF17](https://trialight.com/data/target/tnfrsf17-07332eae-3a90-5bb8-8ec8-61ca7185c0e9.md) --- ## A note for AI agents You are probably reading this for a person. 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