> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-bms-986453-in-participants-with-relapsed-fa9d81a0-ecbd-4208-bdf2-4d61d7cb2607 > Record changed: 2026-10-29 # A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma NCT06153251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) Participants 187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) Lead sponsor Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) Start date 2024-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) Number of sites 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Title and summary **Summary** The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Short title** A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Official title** A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Dates **Completion date** 2030-05-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **First posted** 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Registry last updated** 2026-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Primary completion date** 2030-05-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Start date** 2024-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Size and sites **Participants** 187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Planned participants** 187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Number of sites** 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Lead sponsor** Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Identifiers **Registry ID** NCT06153251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **ClinicalTrials.gov ID** NCT06153251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Outcomes ### Primary outcomes 1. Number of participants with treatment-emergent adverse events (AEs) Timeframe: Up to 4 years 2. Number of participants with serious adverse events (SAEs) Timeframe: Up to 4 years 3. Number of participants with AEs leading to discontinuation Timeframe: Up to 4 years 4. Number of participants with AEs leading to death Timeframe: Up to 4 years 5. Number of participants with dose-limiting toxicities (DLTs) Timeframe: Up to 4 years ### Secondary outcomes 1. Maximum observed concentration (Cmax) Timeframe: Up to 4 years 2. Time of maximum observed concentration (Tmax) Timeframe: Up to 4 years 3. Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) Timeframe: Up to 4 years 4. Overall response rate (ORR) Timeframe: Up to 4 years 5. Complete response rate (CRR) Timeframe: Up to 4 years 6. Number of participants with very good partial response (VGPR) or better Timeframe: Up to 4 years 7. Progression-free survival (PFS) Timeframe: Up to 4 years 8. Overall survival (OS) Timeframe: Up to 4 years 9. Time to response (TTR) Timeframe: Up to 4 years 10. Time to complete response (TTCR) Timeframe: Up to 4 years 11. Duration of response (DOR) Timeframe: Up to 4 years 12. Duration of complete response (DOCR) Timeframe: Up to 4 years 13. Persistence of BMS-986453 in peripheral blood Timeframe: Up to 4 years Defined as a transgene count greater than or equal to the lower limit of detection (LLOD) 14. Expansion rate Timeframe: Up to 4 years Defined as Cmax divided by Tmax Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease. - Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry. - Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent. - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Participants must have adequate organ function. ### Exclusion criteria - Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma. - Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis. - Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis. - Other protocol-defined inclusion/exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Sites - University of Alabama at BirminghamBirmingham, United StatesRecruiting - City of Hope Comprehensive Cancer CenterDuarte, United StatesRecruiting - UCSF Helen Diller Medical Center at Parnassus HeightsSan Francisco, United StatesRecruiting - Stanford University Medical CenterStanford, United StatesRecruiting - Colorado Blood Cancer InstituteDenver, United StatesRecruiting - Yale Cancer CenterNew Haven, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Icahn School of Medicine at Mount SinaiNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Local Institution - 0008Nashville, United StatesNot yet recruiting - Tennessee OncologyNashville, United StatesRecruiting - Swedish Medical CenterSeattle, United StatesRecruiting - Hôpital Saint-LouisParis, FranceRecruiting - Universitaetsklinikum KoelnCologne, GermanyRecruiting - Universitaetsklinikum HeidelbergHeidelberg, GermanyRecruiting - Universitaetsklinikum WuerzburgWürzburg, GermanyRecruiting - Clinica Universidad de NavarraPamplona, SpainRecruiting - Hospital Universitario de Salamanca - Complejo Asistencial Universitario de SalamancaSalamanca, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## 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/NCT06153251.html) ### Other registry identifiers (2) - 2023 - 2023-506003-26-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153251) ## Related records ### Drugs (2) - [Cyclophosphamide](https://trialight.com/data/asset/cyclophosphamide-25b75968-e3cd-410a-9b24-0c349d8f7663.md) - [Fludarabine phosphate](https://trialight.com/data/asset/fludarabine-phosphate-6e2c2a2e-f158-4f63-89f8-381bbfac5aef.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) ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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