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    DRUG CLASS:

    CD19-targeted CAR-T immunotherapy

    Related drugs:
    1d
    QUADvance: Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies (clinicaltrials.gov)
    P1/2, N=178, Not yet recruiting, AvenCell Therapeutics, Inc.
    New P1/2 trial
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    cyclophosphamide • fludarabine IV
    1d
    A Tetrameric Biotin-Avidin Scaffold Using Anti-CD19 (FMC63) Traptavidin Fusion Enables High-Avidity CAR-T Cells for Leukemia Therapy. (PubMed, Bioconjug Chem)
    Notably, tCAR-T exhibited superior antitumor activity compared to Kymriah, with enhanced cytokine release and improved target cell elimination. This innovative approach improves cancer treatment efficacy through enhanced binding avidity and modular targeting flexibility, demonstrating that tCAR-T can overcome limitations of conventional CAR-T therapy and highlighting its potential to improve therapeutic outcomes for cancer patients.
    Journal
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    CD8 (cluster of differentiation 8)
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    Kymriah (tisagenlecleucel-T)
    2d
    Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=12, Recruiting, Zhejiang University | Not yet recruiting --> Recruiting
    Enrollment open
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    Yorwida (inaticabtagene autoleucel)
    3d
    Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation (clinicaltrials.gov)
    P2, N=20, Recruiting, City of Hope Medical Center | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
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    clonoSEQ
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    Opdivo (nivolumab) • Imbruvica (ibrutinib) • cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
    6d
    FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov)
    P1, N=54, Active, not recruiting, Fate Therapeutics | Trial primary completion date: Sep 2024 --> Jun 2025
    Trial primary completion date
    |
    CD19 (CD19 Molecule)
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    cyclophosphamide • fludarabine IV • FT819
    6d
    RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1/2, N=28, Recruiting, Cabaletta Bio | N=12 --> 28 | Trial completion date: Dec 2027 --> Dec 2029 | Trial primary completion date: Dec 2027 --> Dec 2029
    Enrollment change • Trial completion date • Trial primary completion date
    |
    cyclophosphamide • fludarabine IV
    7d
    Autologous Bedside CD19 CAR T-cell Therapy for B-ALL (clinicaltrials.gov)
    P1, N=50, Not yet recruiting, The General Hospital of Western Theater Command
    New P1 trial
    7d
    Emerging role of lisocabtagene maraleucel chimeric antigen receptor-T cell in nodal and gastrointestinal follicular lymphoma. (PubMed, World J Gastroenterol)
    Comparative insights highlight the advantages of liso-cel over other CAR-T cell products, such as axicabtagene ciloleucel and tisagenlecleucel in terms of toxicity, logistics, and outpatient feasibility. With ongoing improvements in manufacturing, accessibility, and biomarker development, liso-cel is well-positioned to become a central component in the evolving treatment paradigm for FL. However, challenges remain regarding durability of response, cost, and access, which warrant careful discussion.
    Review • Journal • IO biomarker
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    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T)
    7d
    A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, Juventas Cell Therapy Ltd.
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • Yorwida (inaticabtagene autoleucel)
    8d
    Long-term Follow up Local Registry Study of Kymriah in South Korea (clinicaltrials.gov)
    P=N/A, N=179, Recruiting, Novartis Pharmaceuticals | N=500 --> 179
    Enrollment change
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    Kymriah (tisagenlecleucel-T)
    8d
    Endothelial dysfunction and proinflammatory state determine severe hematotoxicity and inferior outcome of CAR-T therapy. (PubMed, Hemasphere)
    To identify predictive biomarkers, we performed flow cytometry and multiplex assays before and early after CAR-T infusion on 78 patients (ide-cel n = 31; axi-cel n = 24; and cilta-cel n = 23) undergoing CAR-T therapy. Baseline sIL-2R and sVCAM-1 demonstrated robust predictive value for prolonged neutropenia, severe infections, and mortality independently of key clinical variables such as the underlying disease and CAR-T product. Integration of these markers improves existing models and can help to refine risk assessment and guide individualized patient management in CAR-T therapy.
    Journal • IO biomarker
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    IL2RA (Interleukin 2 receptor, alpha) • VCAM1 (Vascular Cell Adhesion Molecule 1)
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    Yescarta (axicabtagene ciloleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel)
    8d
    PiNACLE-H2H: A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy (clinicaltrials.gov)
    P3, N=400, Recruiting, Lyell Immunopharma, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • rondecabtagene autoleucel (LYL314)