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    DRUG:

    Kymriah (tisagenlecleucel-T)

    i
    Other names: CART 19, CTL019, CTL-019, anti-CD19-CAR retroviral vector-transduced autologous T cells, autologous T cells loaded with a lentiviral vector expressing CART-19, autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR Zeta and 4-1 BB co-stimulatory domains, LG-740, CART 019, anti-CD19-CAR retroviral vector-transduced autologous T cells, Tisa-cel, CART-19, CTL 019, LG 740, LG740
    Company:
    Novartis, University of Pennsylvania
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    3d
    Impact of TP53 alterations on outcomes in pediatric and young adult patients with relapsed / refractory B-cell acute lymphoblastic leukemia after CD19-CAR T-Cell therapy. (PubMed, Bone Marrow Transplant)
    We conducted a single-center retrospective study of 69 patients treated with Tisagenlecleucel, to evaluate the prognostic impact of TP53 alterations (TP53Alt), including mutations and/or deletions...These findings identify TP53 alterations as a strong adverse prognostic factor in patients with r/r B-ALL treated with CAR-T therapy. Screening for TP53Alt may guide risk-adapted strategies, including early consolidation with hematopoietic stem cell transplantation or alternative therapies.
    Journal • IO biomarker
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    TP53 (Tumor protein P53)
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    TP53 mutation • TP53 wild-type
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    Kymriah (tisagenlecleucel-T)
    13d
    FLU-CART: Fludarabine exposure in patients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapy (2025-524278-40-00)
    P4, N=75, Not yet recruiting, Universitair Ziekenhuis Gent
    New P4 trial
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    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Tecartus (brexucabtagene autoleucel) • Carvykti (ciltacabtagene autoleucel)
    17d
    BELINDA: Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P3, N=331, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
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    ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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    cyclophosphamide • Kymriah (tisagenlecleucel-T) • fludarabine IV
    1m
    Long-term Follow up Local Registry Study of Kymriah in South Korea (clinicaltrials.gov)
    P=N/A, N=500, Recruiting, Novartis Pharmaceuticals | N=179 --> 500
    Enrollment change
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    Kymriah (tisagenlecleucel-T)
    2ms
    Study of Out of Specification for Tisagenlecleucel (clinicaltrials.gov)
    P3, N=200, Recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Apr 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
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    Kymriah (tisagenlecleucel-T)
    2ms
    LEDA: A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (clinicaltrials.gov)
    P3, N=109, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
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    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Kymriah (tisagenlecleucel-T) • fludarabine IV
    2ms
    Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies (clinicaltrials.gov)
    P1, N=20, Recruiting, Stanford University | Trial completion date: Nov 2025 --> Jul 2026 | Trial primary completion date: Nov 2025 --> Jul 2026
    Trial completion date • Trial primary completion date
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    CD22 (CD22 Molecule)
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    Kymriah (tisagenlecleucel-T) • firicabtagene autoleucel (CRG-022)
    2ms
    REFUEL: A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2026 --> Jul 2027 | Trial primary completion date: Jul 2026 --> Jul 2027
    Trial completion date • Trial primary completion date
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    CD19 (CD19 Molecule) • IFNG (Interferon, gamma)
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    Kymriah (tisagenlecleucel-T)
    2ms
    Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=396, Recruiting, SWOG Cancer Research Network | Trial completion date: Dec 2029 --> Jun 2030 | Trial primary completion date: Dec 2025 --> Jun 2030
    Trial completion date • Trial primary completion date
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    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
    2ms
    Lythesia: A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy (clinicaltrials.gov)
    P=N/A, N=30, Not yet recruiting, Novartis Pharmaceuticals
    New trial
    |
    Kymriah (tisagenlecleucel-T)
    2ms
    Precision immunotherapy with CAR-T cells in pediatric B-cell acute lymphoblastic leukemia: advances and unanswered challenges. (PubMed, Front Oncol)
    CD19-targeted CAR T cells, such as tisagenlecleucel, have demonstrated high rates of complete remission and long-lasting responses in clinical trials...Despite these innovations, further research is needed to refine manufacturing processes, reduce costs, and improve long-term outcomes. This review emphasizes the transformative potential of CAR-T therapy for pediatric B-ALL and discusses critical challenges and future directions in the field.
    Review • Journal
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    CD22 (CD22 Molecule)
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    Kymriah (tisagenlecleucel-T)
    2ms
    CAR-T cells with the CD38-CD73-Tim-3-HLA-DR+ phenotype predict the efficacy of tisagenlecleucel as a treatment for B cell precursor ALL. (PubMed, Cell Rep Med)
    By contrast, CARpos T cells obtained from infusion products in long-term responders are enriched in the CD38-CD73-Tim-3-HLA-DR+ phenotype, characterized by a decreased ability to produce adenosine, memory-like transcriptomic characteristics, and leveraging of mitochondrial metabolism and oxidative phosphorylation. Our study reveals that the CD38-CD73-Tim-3-HLA-DR+ phenotype contributes to long-term remission in patients with BCP-ALL who receive tisagenlecleucel.
    Journal
    |
    CD73 (5'-Nucleotidase Ecto) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CXCR3 (C-X-C Motif Chemokine Receptor 3)
    |
    Kymriah (tisagenlecleucel-T)