A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma

Summary

The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).

Timeline

Start

2018-06-29

Primary completion

2022-08-23

Completion

2022-08-23

Publications

• Lopez-Munoz N, Bar N, Diels J, van Sanden S, Mendes J, Lee S, Hernando T, Lendvai N, Patel N, Ishida T, Er J, Harrison SJ. Ciltacabtagene Autoleucel Versus Idecabtagene Vicleucel in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma with 2-4 Prior Lines of Therapy: Updated Matching-Adjusted Indirect Comparison. Adv Ther. 2026 Mar;43(3):1327-1340. doi: 10.1007/s12325-025-03479-y. Epub 2026 Feb 2.
• Jagannath S, Martin TG, Lin Y, Cohen AD, Raje N, Htut M, Deol A, Agha M, Berdeja JG, Lesokhin AM, Liegel JJ, Rossi A, Lieberman-Cribbin A, Usmani SZ, Dhakal B, Parekh S, Li H, Wang F, Montes de Oca R, Plaks V, Sun H, Banerjee A, Schecter JM, Lendvai N, Madduri D, Lengil T, Zhu J, Koneru M, Akram M, Patel N, Costa Filho O, Jakubowiak AJ, Voorhees PM. Long-Term (>/=5-Year) Remission and Survival After Treatment With Ciltacabtagene Autoleucel in CARTITUDE-1 Patients With Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2025 Sep;43(25):2766-2771. doi: 10.1200/JCO-25-00760. Epub 2025 Jun 3.
• Palmer S, Lin Y, Martin TG, Jagannath S, Jakubowiak A, Usmani SZ, Buyukkaramikli N, Phelps H, Slowik R, Pan F, Valluri S, Pacaud L, Jackson G. Extrapolation of Survival Data Using a Bayesian Approach: A Case Study Leveraging External Data from Cilta-Cel Therapy in Multiple Myeloma. Oncol Ther. 2023 Sep;11(3):313-326. doi: 10.1007/s40487-023-00230-x. Epub 2023 Jun 4.
• Raghunandan S, Pauly M, Blum WG, Qayed M, Dhodapkar MV, Elkhalifa M, Watkins B, Schoettler M, Horwitz E, Parikh S, Chandrakasan S, Leung K, Bryson E, Deeb L, Kaufman JL, Worthington-White D, Alazraki A, Schecter JM, Madduri D, Jackson CC, Zudaire E, Taraseviciute-Morris A, Babich A, Nesheiwat T, Vogel M, Lendvai N, Pacaud L, Williams KM. BCMA CAR-T induces complete and durable remission in refractory plasmablastic lymphoma. J Immunother Cancer. 2023 May;11(5):e006684. doi: 10.1136/jitc-2023-006684.
• Mateos MV, Weisel K, Martin T, Berdeja JG, Jakubowiak A, Stewart AK, Jagannath S, Lin Y, Diels J, Ghilotti F, Thilakarathne P, Perualila NJ, Cabrieto J, Haefliger B, Erler-Yates N, Hague C, Jackson CC, Schecter JM, Strulev V, Nesheiwat T, Pacaud L, Einsele H, Moreau P. Adjusted comparison of outcomes between patients from CARTITUDE-1 versus multiple myeloma patients with prior exposure to proteasome inhibitors, immunomodulatory drugs and anti-CD38 antibody from the prospective, multinational LocoMMotion study of real-world clinical practice. Haematologica. 2023 Aug 1;108(8):2192-2204. doi: 10.3324/haematol.2022.280482.
• Cohen AD, Hari P, Htut M, Berdeja JG, Usmani SZ, Madduri D, Olyslager Y, Goldberg JD, Schecter JM, Jackson CC, Gries KS, Fastenau JM, Valluri S, Deraedt W, Akram M, Crawford R, Morrison R, Doward L, Morgan K, Seldam ST, Jakubowiak A, Jagannath S. Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):68-77. doi: 10.1016/j.clml.2022.10.001. Epub 2022 Oct 11.
• Martin T, Lin Y, Agha M, Cohen AD, Htut M, Stewart AK, Hari P, Berdeja JG, Usmani SZ, Yeh TM, Olyslager Y, Goldberg JD, Schecter JM, Madduri D, Jackson CC, Deraedt W, Gries KS, Fastenau JM, Trudeau JJ, Akram M, Pacaud L, Jakubowiak A, Jagannath S. Health-related quality of life in patients given ciltacabtagene autoleucel for relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b-2, open-label study. Lancet Haematol. 2022 Dec;9(12):e897-e905. doi: 10.1016/S2352-3026(22)00284-8. Epub 2022 Oct 7.
• Wu LS, Su Y, Li C, Zhou W, Jackson CC, Sun YN, Zhou H. Population-based cellular kinetic characterization of ciltacabtagene autoleucel in subjects with relapsed or refractory multiple myeloma. Clin Transl Sci. 2022 Dec;15(12):3000-3011. doi: 10.1111/cts.13421. Epub 2022 Oct 6.
• Martin T, Usmani SZ, Berdeja JG, Agha M, Cohen AD, Hari P, Avigan D, Deol A, Htut M, Lesokhin A, Munshi NC, O'Donnell E, Stewart AK, Schecter JM, Goldberg JD, Jackson CC, Yeh TM, Banerjee A, Allred A, Zudaire E, Deraedt W, Olyslager Y, Zhou C, Pacaud L, Madduri D, Jakubowiak A, Lin Y, Jagannath S. Ciltacabtagene Autoleucel, an Anti-B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up. J Clin Oncol. 2023 Feb 20;41(6):1265-1274. doi: 10.1200/JCO.22.00842. Epub 2022 Jun 4.
• Van Oekelen O, Aleman A, Upadhyaya B, Schnakenberg S, Madduri D, Gavane S, Teruya-Feldstein J, Crary JF, Fowkes ME, Stacy CB, Kim-Schulze S, Rahman A, Lagana A, Brody JD, Merad M, Jagannath S, Parekh S. Neurocognitive and hypokinetic movement disorder with features of parkinsonism after BCMA-targeting CAR-T cell therapy. Nat Med. 2021 Dec;27(12):2099-2103. doi: 10.1038/s41591-021-01564-7. Epub 2021 Dec 10.
• Berdeja JG, Madduri D, Usmani SZ, Jakubowiak A, Agha M, Cohen AD, Stewart AK, Hari P, Htut M, Lesokhin A, Deol A, Munshi NC, O'Donnell E, Avigan D, Singh I, Zudaire E, Yeh TM, Allred AJ, Olyslager Y, Banerjee A, Jackson CC, Goldberg JD, Schecter JM, Deraedt W, Zhuang SH, Infante J, Geng D, Wu X, Carrasco-Alfonso MJ, Akram M, Hossain F, Rizvi S, Fan F, Lin Y, Martin T, Jagannath S. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021 Jul 24;398(10297):314-324. doi: 10.1016/S0140-6736(21)00933-8. Epub 2021 Jun 24.

Drugs

Indications