^
    4ms
    Multi-antigen Specific CD8+ T Cells With Decitabine and Lymphodepleting Chemotherapy for the Treatment of Patients With Relapsed or Refractory AML or MDS Following an Allogeneic Hematopoietic Cell Transplantation From a Matched Donor (clinicaltrials.gov)
    P1, N=31, Not yet recruiting, City of Hope Medical Center
    New P1 trial
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    cyclophosphamide • decitabine • fludarabine IV • NEXI-001
    11ms
    Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT (clinicaltrials.gov)
    P1/2, N=22, Active, not recruiting, NexImmune Inc. | Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Mar 2025 | Trial primary completion date: Oct 2022 --> Oct 2024
    Enrollment closed • Trial completion date • Trial primary completion date
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    HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
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    cyclophosphamide • NEXI-001
    over1year
    An analysis of a first-in-human study of NEXI-001 donor-derived antigen-specific CD8+ T-cell treatment of relapsed AML after allogeneic hematopoietic cell transplantation (HCT). (ASCO 2023)
    Early results indicate that the antigen-specific NEXI-001 T cells have the potential to enhance GvL effects and is tolerated with easily manageable side effects. Greater clinical activity has been observed with increased doses of the NEXI-001 T cells. The trial remains ongoing, and the data support an Expansion Cohort of the study that will allow for a more complete assessment of clinical activity.
    P1 data
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    CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule) • PRAME (Preferentially Expressed Antigen In Melanoma) • CCNA1 (Cyclin A1)
    |
    NEXI-001
    2years
    Initial Characterization of Nexi-001, a Donor-Derived T-Cell Product, for the Treatment AML Patients That Have Relapsed after Allogeneic Hematopoietic Stem Cell Transplant (ASH 2022)
    In summary, we have developed a novel AIM np-based T cell expansion platform for the rapid, streamlined generation of clinically relevant number of tumor-specific, multi-antigen, memory CD8+ T cells in 14 days. The results reported here support the development of additional multi-institution phase 1 /2 clinical trials of adoptive T cell transfer in hematologic and solid cancers.
    Clinical
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    CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • PRAME (Preferentially Expressed Antigen In Melanoma) • CCNA1 (Cyclin A1)
    |
    NEXI-001
    3years
    Phase 1/2 Study of Nexi-001 Donor-Derived Multi-Antigen Specific CD8+ T Cells for the Treatment of Relapsed Acute Myeloid Leukemia (AML) after Allogeneic Hematopoietic Transplantation (ASH 2021)
    Bridging anti-AML treatment was permitted during the manufacture of the cellular product with a wash-out period of at least 14 days prior to lymphodepletion (LD) chemotherapy (intravenous fludarabine 30 mg/m 2 and cyclophosphamide 300 mg/m 2 ) that was administered on Days -5, -4, and -3 prior to the infusion of the NEXI-001 product up to 72 hours later (Day1). At least two cycles of 200M NEXI-001 cells weekly x 3 weeks of a 4-week cycle is planned for the next dose-escalation cohort. Early data suggest that the NEXI-001 product has the potential to enhance a GvL effect with minimal GVHD-associated toxicities.
    P1/2 data
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    CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule) • PRAME (Preferentially Expressed Antigen In Melanoma) • CCNA1 (Cyclin A1)
    |
    cyclophosphamide • fludarabine IV • NEXI-001
    over3years
    [VIRTUAL] Preliminary analysis of a phase 1/2 study of NEXI-001 donor-derived multi-antigen-specific CD8+ T-cells for the treatment of relapsed acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (HCT). (ASCO 2021)
    NEXI-001 has the potential to enhance GvL effect without the associated toxicities of GVHD, cytokine release syndrome, and neurotoxicity . Due to these encouraging results, the trial will proceed with an evaluation of repeated NEXI-001 dosing
    P1/2 data
    |
    CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    NEXI-001