^
    27d
    Using the iCasp9 suicide strategy to control the growth and function of genome-edited B cells with redirected antigen specificity. (PubMed, Mol Ther Oncol)
    Although AP1903 treatment strongly curbed edited cell survival, this was constantly followed by the selection of resistant cells with lowered expression of both iCasp9 and the therapeutic antibody cassette. Therefore, in adoptive immunotherapy protocols, the iCasp9/AP1903 safety switch could stand as an efficient neoadjuvant therapy, as well as a rheostat to modulate the infusion of a therapeutic molecule.
    Journal • IO biomarker
    |
    CASP9 (Caspase 9)
    |
    rimiducid (AP1903)
    2ms
    Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma (clinicaltrials.gov)
    P1, N=19, Active, not recruiting, UNC Lineberger Comprehensive Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 19 | Trial completion date: Mar 2043 --> Jul 2040 | Trial primary completion date: Mar 2027 --> Aug 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • IRF4 (Interferon regulatory factor 4)
    |
    ALK positive
    |
    cyclophosphamide • fludarabine IV • rimiducid (AP1903)
    2ms
    P-BCMA-ALLO1-001: P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma (clinicaltrials.gov)
    P1, N=275, Recruiting, Poseida Therapeutics, Inc. | Trial completion date: Dec 2039 --> Mar 2042 | Trial primary completion date: Dec 2027 --> Mar 2029
    Trial completion date • Trial primary completion date
    |
    RG6538 • rimiducid (AP1903)
    3ms
    Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL (clinicaltrials.gov)
    P1/2, N=17, Active, not recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: Aug 2040 --> Sep 2037 | Trial primary completion date: Dec 2025 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD19 (CD19 Molecule)
    |
    CD19 positive
    |
    cyclophosphamide • fludarabine IV • iC9-CAR19 cells • rimiducid (AP1903)
    3ms
    Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL (clinicaltrials.gov)
    P1/2, N=17, Active, not recruiting, UNC Lineberger Comprehensive Cancer Center | Recruiting --> Active, not recruiting | N=54 --> 17 | Trial completion date: Apr 2041 --> Aug 2040 | Trial primary completion date: Apr 2026 --> Dec 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD19 (CD19 Molecule)
    |
    CD19 positive
    |
    cyclophosphamide • fludarabine IV • iC9-CAR19 cells • rimiducid (AP1903)
    4ms
    Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    cyclophosphamide • fludarabine IV • rimiducid (AP1903)
    7ms
    Side_by_Cide: T Lymphocytes (LT) Expressing iCASP9 and ΔCD19 in Allogeneic Haematopoietic Transplantation. (clinicaltrials.gov)
    P1/2, N=2, Terminated, Centre Hospitalier Universitaire de Besancon | N=12 --> 2 | Unknown status --> Terminated; not enough recruitment because of new therapeutic alternatives
    Enrollment change • Trial termination
    |
    rimiducid (AP1903)
    7ms
    T-Cell Therapy for Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=186, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSLN (Mesothelin)
    |
    HER-2 negative
    |
    cyclophosphamide • rimiducid (AP1903)
    8ms
    A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov)
    P1, N=162, Not yet recruiting, Genentech, Inc.
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • RG6540 • rimiducid (AP1903)
    11ms
    P-MUC1C-ALLO1-001: P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects with Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=180, Active, not recruiting, Poseida Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    P-MUC1C-ALLO1 • rimiducid (AP1903)
    11ms
    P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC) (clinicaltrials.gov)
    P1, N=40, Terminated, Poseida Therapeutics, Inc. | N=60 --> 40 | Trial completion date: Sep 2036 --> Sep 2024 | Active, not recruiting --> Terminated; Study closed
    Enrollment change • Trial completion date • Trial termination
    |
    rimiducid (AP1903)
    1year
    PSCA-targeted BPX-601 CAR T cells with pharmacological activation by rimiducid in metastatic pancreatic and prostate cancer: a phase 1 dose escalation trial. (PubMed, Nat Commun)
    Rimiducid increased circulating inflammatory cytokines/chemokines consistent with GoCAR-T® cell activation. These results suggest that pharmacological activation of GoCAR-T® cells is feasible and may offer a promising avenue to control chimeric antigen receptor-T cell activity with continued dose-optimization to improve tolerability.
    P1 data • Journal
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • CD40 (CD40 Molecule) • PSCA (Prostate Stem Cell Antigen 2)
    |
    BPX-601 • rimiducid (AP1903)