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    DRUG:

    Breyanzi (lisocabtagene maraleucel)

    i
    Other names: JCAR017, anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, CD19-CAR T cell immunotherapy, CD19 specific CAR T cells also expressing an EGFRt, anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, JCAR 017, liso-cel, JCAR-017
    Company:
    BMS
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    4d
    Current Treatment of Double Refractory Chronic Lymphocytic Leukemia: A Focus on Novel Drugs. (PubMed, Clin Lymphoma Myeloma Leuk)
    Noncovalent BTK inhibitors, particularly pirtobrutinib, has shown impressive activity in patients who have progressed on covalent BTKi. The FDA approval of lisocabtagene maraleucel represents a significant milestone in the treatment of double refractory CLL, providing a potentially curative option for eligible patients. The development of effective treatments for double refractory CLL represents an urgent unmet clinical need and the promising results from emerging therapies offer hope for improved outcomes in this challenging patient population.
    Review • Journal
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    BCL2 (B-cell CLL/lymphoma 2)
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    Breyanzi (lisocabtagene maraleucel) • Jaypirca (pirtobrutinib)
    13d
    LTFU: Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells (clinicaltrials.gov)
    P2/3, N=312, Recruiting, Celgene | N=214 --> 312
    Enrollment change
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    Breyanzi (lisocabtagene maraleucel) • Abecma (idecabtagene vicleucel)
    14d
    A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma (clinicaltrials.gov)
    P2, N=65, Recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
    Trial initiation date
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    Rituxan (rituximab) • temozolomide • cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • leucovorin calcium • fludarabine IV • Matulane (procarbazine hydrochloride)
    20d
    A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov)
    P3, N=0, Withdrawn, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | N=300 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
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    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Breyanzi (lisocabtagene maraleucel) • bendamustine • fludarabine IV
    2ms
    CA082-1215: Efficacy and Safety of Lisocabtagene Maraleucel (liso-cel) as First-Line Therapy in Adults with Transplant-Ineligible Primary Central Nervous System Lymphoma (2025-521144-38-00)
    P1/2, N=31, Recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P1/2 trial
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    Rituxan (rituximab) • temozolomide • cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • leucovorin calcium • fludarabine IV • Matulane (procarbazine hydrochloride) • Actemra IV (tocilizumab)
    2ms
    NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=24, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open
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    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Hyleukin-7 (efineptakin alfa)
    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
    Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas (clinicaltrials.gov)
    P2, N=28, Active, not recruiting, Patrick C. Johnson, MD | Recruiting --> Active, not recruiting
    Enrollment closed
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    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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    cyclophosphamide • Calquence (acalabrutinib) • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
    3ms
    Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL (clinicaltrials.gov)
    P1/2, N=30, Suspended, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Dec 2026 | Recruiting --> Suspended | Trial primary completion date: Dec 2025 --> Sep 2026
    Trial completion date • Trial suspension • Trial primary completion date
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    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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    LDH elevation
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    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Lymphir (denileukin diftitox-cxdl)
    3ms
    Impact of CD5 expression on outcomes for chimeric antigen receptor-T cell therapy in relapsed and refractory diffuse large B-cell lymphoma. (PubMed, Cytotherapy)
    To investigate this clinical issue, 106 patients treated with CAR-T cell therapy using either tisagenlecleucel, lisocabtagene maraleucel or axicabtagene ciloleucel for r/r DLBCL at our institution were retrospectively analyzed. Multivariate analysis revealed that CD5 expression was unfavorably associated with PFS and OS. Together, these data suggest that CD5 expression has a negative impact on outcomes after CAR-T cell therapy.
    Journal • IO biomarker
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    CD5 (CD5 Molecule)
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    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T)
    3ms
    Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Fred Hutchinson Cancer Center | Initiation date: Dec 2025 --> Apr 2026
    Trial initiation date
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    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • nemtabrutinib (MK-1026)
    3ms
    Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial • Minimal residual disease
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    BCL2 (B-cell CLL/lymphoma 2)
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    Foresight CLARITY™
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    Breyanzi (lisocabtagene maraleucel)