^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    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:
    8d
    Lythesia: A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy (clinicaltrials.gov)
    P=N/A, N=30, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Kymriah (tisagenlecleucel-T)
    12d
    Impaired hematopoiesis affects apheresis and CAR T-cell product composition and treatment response. (PubMed, Transfusion)
    These findings highlight the importance of early leukapheresis, ideally before intensive treatments, to optimize T-cell yield, product quality, and therapeutic efficacy.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • HD-CAR-1
    18d
    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
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    Kymriah (tisagenlecleucel-T)
    28d
    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
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Tecartus (brexucabtagene autoleucel) • Carvykti (ciltacabtagene autoleucel)
    1m
    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
    |
    ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    cyclophosphamide • Kymriah (tisagenlecleucel-T) • fludarabine IV
    2ms
    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
    |
    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
    |
    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
    |
    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
    |
    CD22 (CD22 Molecule)
    |
    Kymriah (tisagenlecleucel-T) • firicabtagene autoleucel (CRG-022)
    3ms
    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
    |
    CD19 (CD19 Molecule) • IFNG (Interferon, gamma)
    |
    Kymriah (tisagenlecleucel-T)
    3ms
    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
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
    3ms
    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)