CARTITUDE-1

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A Phase 1b-2, Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

Phase

Phase 1/Phase 2

Status

Completed

Conditions

Multiple Myeloma

Interventions

JNJ-68284528

Arms

• JNJ-68284528 · Experimental

Enrollment

126

Primary outcomes

• Phase 1b: Number of Participants With Adverse Events as Per Severity
• Phase 2: Overall Response Rate (ORR)

Sponsor

Janssen Research & Development, LLC

Start

Jun 29, 2018

Primary completion

Aug 23, 2022

Results posted

Yes

Registry record

NCT03548207 · updated Jul 30, 2025

• 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. PubMed 41627370
• 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. PubMed 40459151
• 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. PubMed 37270762
• 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. PubMed 37137553
• 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. PubMed 36546453
• 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. PubMed 36357295
• 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. PubMed 36215989
• 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. PubMed 36204820
• 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. PubMed 35658469
• 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. PubMed 34893771
• 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. PubMed 34175021