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    DRUG:

    Carvykti (ciltacabtagene autoleucel)

    i
    Other names: JNJ-4528, JNJ 4528, cilta-cel, JNJ4528, JNJ68284528, LCARB38M, LCAR B38M, LCAR-B38M, anti-BCMA CAR-T, LCAR-B38M CAR-T, JNJ-68284528, JNJ 68284528
    Company:
    J&J, Legend Biotech
    Drug class:
    BCMA-targeted CAR-T immunotherapy
    Related drugs:
    11d
    Robust CD4 + CAR T cell Expansion Is Associated with Non-ICANS Neurotoxicities Following Ciltacabtagene Autoleucel. (PubMed, medRxiv)
    Finally, we characterize NINT associated CD4 + CAR T cell populations which are potential therapeutic targets for future exploration. Ciltacabtagene autoleucel associated non-ICANS neurotoxicities are driven by high CD4 + CAR T cell expansion exhibiting memory marker expression and upregulated inflammatory gene signaling pathways.
    Journal
    |
    CD4 (CD4 Molecule)
    |
    Carvykti (ciltacabtagene autoleucel)
    20d
    Integrated clinical and single-cell profiling of BCMA CAR-T therapy in relapsed/refractory multiple myeloma. (PubMed, J Transl Med)
    Locally produced BCMA CAR-T is safe and effective in heavily pretreated R/R MM, inducing deep responses. scRNA-seq/TCR-seq findings highlight interplay of CAR-T heterogeneity, clonal adaptability, and immune regulation. CD8⁺ subset specialization and clonal persistence matter for durable responses; exhaustion and immunosuppression may cause relapse.
    Journal
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6)
    |
    Actemra IV (tocilizumab) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel)
    22d
    CARTITUDE-4: A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (clinicaltrials.gov)
    P3, N=419, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2036 --> Apr 2029
    Trial completion date • IO biomarker
    |
    lenalidomide • bortezomib • cyclophosphamide • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel)
    24d
    MonumenTAL-8: A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=11, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs)
    2ms
    Chronic inflammatory demyelinating polyneuropathy (CIDP) after cilta-cel therapy. (PubMed, Blood Cancer J)
    High-dose dexamethasone plus intravenous immunoglobulin failed to improve neurologic symptoms and prompted T-cell-depleting cyclophosphamide, which lowered CAR- and non-CAR-T cells. These observations indicate that CIDP is a severe complication of cilta-cel therapy and may arise from bystander expansion of autoreactive CD8⁺ T-cells rather than direct CAR-T cell activity. Timely escalation to T-cell-depleting therapy may improve outcomes.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    cyclophosphamide • Carvykti (ciltacabtagene autoleucel) • dexamethasone injection
    2ms
    CARTITUDE-4: A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (clinicaltrials.gov)
    P3, N=419, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2029 --> Sep 2036
    Trial completion date • IO biomarker
    |
    lenalidomide • bortezomib • cyclophosphamide • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel)
    2ms
    aMMbition: A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    lenalidomide • bortezomib • cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    2ms
    CARTITUDE-5: A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (clinicaltrials.gov)
    P3, N=743, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2034 --> Sep 2036
    Trial completion date • IO biomarker
    |
    lenalidomide • bortezomib • cyclophosphamide • fludarabine IV • Carvykti (ciltacabtagene autoleucel)
    2ms
    MonumenTAL-8: A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=10, Recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2026 --> Nov 2026
    Trial completion date
    |
    Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs)
    2ms
    Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Washington University School of Medicine
    New P1 trial
    |
    clonoSEQ
    |
    Carvykti (ciltacabtagene autoleucel) • Hyleukin-7 (efineptakin alfa)
    3ms
    A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel (clinicaltrials.gov)
    P2, N=60, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    bortezomib • cyclophosphamide • Darzalex (daratumumab) • fludarabine IV • Carvykti (ciltacabtagene autoleucel)
    3ms
    CARTITUDE-5: A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (clinicaltrials.gov)
    P3, N=743, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jun 2026 --> Feb 2029
    Trial primary completion date • IO biomarker
    |
    lenalidomide • bortezomib • cyclophosphamide • fludarabine IV • Carvykti (ciltacabtagene autoleucel)