^
    6ms
    Development of a workflow for in vitro on- and off-target cytotoxicity assessment of CAR T cell therapies to support first-in-human clinical trials: An orthogonal approach using human induced pluripotent stem cell-derived cells as a surrogate for normal vital organ systems. (PubMed, Curr Res Toxicol)
    Experimental considerations including assay and cell model qualification are presented, and an orthogonal workflow described. Finally, an illustrative case of experimental CD33 CAR T cells co-cultured with a select panel of hiPSC-derived normal cells serves as a springboard for other CAR T cell developers to consider in their nonclinical safety programs.
    P1 data • Preclinical • Journal
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    CD33 (CD33 Molecule)
    |
    anti-CD33 CAR T
    10ms
    CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=27, Recruiting, City of Hope Medical Center | Trial completion date: Sep 2026 --> Sep 2028 | Trial primary completion date: Sep 2026 --> Sep 2028
    Trial completion date • Trial primary completion date
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    anti-CD33 CAR T
    2years
    CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=27, Recruiting, City of Hope Medical Center | Trial completion date: Nov 2025 --> Sep 2026 | Trial primary completion date: Nov 2025 --> Sep 2026
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    anti-CD33 CAR T
    over2years
    CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=27, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Aug 2023
    Enrollment open • Trial initiation date • CAR T-Cell Therapy
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    anti-CD33 CAR T
    over2years
    Combining Anti-CD33 Chimeric Antigen-Receptor T Cells with the Hypomethylating Agent Decitabine to Treat Acute Myeloid Leukemia (ASGCT 2023)
    Acute myeloid leukemia (AML) is the most common acute leukemia in adults, causing >10,000 deaths per year in the United States. Moreover, DAC treatment resulted in downregulation of DNA repair pathways, β-Catenin, and Notch signaling pathways.Taken together, we found that the antileukemia activity of CD33 CAR T cells was enhanced by pretreatment of leukemia cells with DAC. This combination represents a clinically relevant therapy for the treatment of patients with r/r AML.
    CAR T-Cell Therapy
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    DNMT3A (DNA methyltransferase 1) • CD8 (cluster of differentiation 8) • CD33 (CD33 Molecule) • CD4 (CD4 Molecule) • DNMT1 (DNA methyltransferase 1) • DNMT3B (DNA Methyltransferase 3 Beta)
    |
    decitabine • anti-CD33 CAR T
    almost3years
    CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=27, Not yet recruiting, City of Hope Medical Center
    New P1 trial • CAR T-Cell Therapy
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    anti-CD33 CAR T