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    DRUG:

    GM.CD40L cell vaccine

    i
    Other names: GM.CD40L cell vaccine, GM-CSF-producing and CD40L-expressing bystander cell line vaccine, dendristim vaccine, CD40L GVAX, autologous tumour cell-based vaccine, bystander-based autologous tumour cell vaccine, hCD40L/hGM-CSF, GM.CD40L, GM-CSF/CD40L, bystander-based autologous tumor cell vaccine, bystander vaccine, GM.CD40L bystander vaccine, CD40LGVAX
    Associations

    News

    Trials
    Company:
    AbelZeta Pharma, H. Lee Moffitt Cancer Center and Research Institute, University of South Florida
    Drug class:
    CD40 agonist
    Related drugs:
    Associations

    News

    Trials
    9ms
    Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=43, Completed, H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting --> Completed
    Trial completion • Tumor cell
    |
    IFNG (Interferon, gamma)
    |
    cytarabine • doxorubicin hydrochloride • cyclophosphamide • vincristine • Proleukin (aldesleukin) • GM.CD40L cell vaccine
    1year
    XMT-1660: A phase 1b trial of a B7-H4 targeted antibody drug conjugate (ADC) in breast, endometrial, and ovarian cancers. (ASCO 2023)
    XMT-1660 is a B7-H4-directed Dolasynthen antibody drug conjugate designed with a precise, optimized drug-to-antibody ratio and a DolaLock microtubule inhibitor payload with controlled bystander effect. NCT05377996. Clinical trial information: NCT05377996.
    P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4) • VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    HER-2 negative • VTCN1 underexpression • VTCN1 overexpression
    |
    emiltatug ledadotin (XMT-1660) • GM.CD40L cell vaccine
    almost2years
    Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2022 --> Jul 2023
    Preclinical • Trial completion date
    |
    IFNG (Interferon, gamma)
    |
    cytarabine • doxorubicin hydrochloride • cyclophosphamide • vincristine • Proleukin (aldesleukin) • GM.CD40L cell vaccine
    almost2years
    Phase II clinical study evaluating the efficacy and safety of disitamab vedotin in patients (pts) with HER2-expressing urothelial carcinoma (RC48G001) (ESMO 2022)
    Nearly half of all pts cannot tolerate standard cisplatin-based first line (1L) chemotherapy and opportunity still exists to improve outcomes in both 1L and later lines of therapy...DV elicits antitumor activity through MMAE-directed cytotoxicity and bystander effect (Li 2020)...Secondary endpoints include ORR assessed by investigator, duration of response, progression-free survival, disease control rate, overall survival, safety, and pharmacokinetic parameters. Enrollment for cohorts A and B is ongoing in North America and EU, and planned in LATAM, APAC, and Israel.
    Clinical • P2 data
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 expression
    |
    cisplatin • Aidixi (disitamab vedotin) • GM.CD40L cell vaccine
    over2years
    Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2021 --> Jul 2022
    Preclinical • Trial completion date
    |
    IFNG (Interferon, gamma)
    |
    doxorubicin hydrochloride • cyclophosphamide • vincristine • Proleukin (aldesleukin) • GM.CD40L cell vaccine
    over3years
    The Calcitriol/Vitamin D Receptor System Regulates Key Immune Signaling Pathways in Chronic Lymphocytic Leukemia. (PubMed, Cancers (Basel))
    To this end, we performed expression analysis of the vitamin D pathway molecules; complemented by RNA-Sequencing analysis in primary CLL cells that were treated in vitro with calcitriol, the biologically active form of vitamin D. In addition, we examined calcitriol effects ex vivo in CLL cells cultured in the presence of microenvironmental signals, namely anti-IgM/CD40L, or co-cultured with the supportive HS-5 cells; and, CLL cells from patients under ibrutinib treatment. This finding was also supported by our finding of preserved calcitriol signaling capacity in CLL patients under ibrutinib treatment. Overall, our results indicate a relevant biological role for vitamin D in CLL pathophysiology and allude to the potential clinical utility of vitamin D supplementation in patients with CLL.
    Journal
    |
    CD40LG (CD40 ligand)
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    Imbruvica (ibrutinib) • GM.CD40L cell vaccine
    over3years
    Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2020 --> Jul 2021
    Preclinical • Trial completion date
    |
    IFNG (Interferon, gamma)
    |
    doxorubicin hydrochloride • vincristine • Proleukin (aldesleukin) • GM.CD40L cell vaccine
    over4years
    Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2019 --> Dec 2020
    Preclinical • Trial completion date
    |
    IFNG (Interferon, gamma)
    |
    doxorubicin hydrochloride • vincristine • Proleukin (aldesleukin) • GM.CD40L cell vaccine