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    DRUG:

    Orca-T

    i
    Other names: Orca-T, TregGraft
    Company:
    Orca Biosystems
    Drug class:
    Immunomodulator
    Related drugs:
    2ms
    Reduced Intensity or Nonmyeloablative Conditioning With Orca-T for Acute Myelogenous Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=80, Recruiting, Orca Biosystems, Inc.
    New P2 trial
    |
    Orca-T
    3ms
    Myeloablative Conditioning Orca-T & Allogeneic Donor-Derived CD19/CD22-CAR TCells in B-Cell ALL (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, Stanford University | Trial completion date: Jan 2037 --> May 2026 | Trial primary completion date: Jan 2037 --> May 2026 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule) • KMT2A (Lysine Methyltransferase 2A) • CRLF2 (Cytokine Receptor Like Factor 2) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    KMT2A rearrangement
    |
    Orca-T • firicabtagene autoleucel (CRG-022)
    5ms
    Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Stanford University | Initiation date: Jun 2025 --> Sep 2025
    Trial initiation date
    |
    Jakafi (ruxolitinib) • Orca-T
    7ms
    Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (clinicaltrials.gov)
    P1, N=255, Active, not recruiting, Orca Biosystems, Inc. | Trial completion date: Jul 2026 --> Apr 2027 | Trial primary completion date: Jul 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    Orca-T
    8ms
    Precision-T (PhIII component): Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (clinicaltrials.gov)
    P3, N=174, Active, not recruiting, Orca Biosystems, Inc. | Trial primary completion date: Apr 2025 --> Jul 2024 | Trial completion date: Apr 2027 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    Orca-T
    1year
    Safe and Effective Combination of Donor-Derived, Allogeneic CD19/CD22-CAR T Cells with Myeloablative Graft-Engineered Allo-HCT for High-Risk B-ALL (ASH 2024)
    Myeloablative conditioning with cyclophosphamide and total body irradiation precede infusion of investigational Orca-T, which consists of infusions of HSPCs and Tregs on Day 0 and an infusion of T conventional (Tcon) cells on Day 2. This paradigm shifting combination of allogeneic CAR T and allo-HCT resulted in 100% MRD- CR with full donor chimerism but without GVHD or severe CAR-mediated toxicity. These data, which demonstrate antigen-specific anti-tumor benefit of allogeneic CAR T cells in combination with GVHD prophylaxis mediated by Tregs and tacrolimus, have potential implications that could benefit patients with other hematologic diseases.
    CAR T-Cell Therapy • IO biomarker
    |
    TP53 (Tumor protein P53) • ABL1 (ABL proto-oncogene 1) • CD22 (CD22 Molecule)
    |
    TP53 mutation
    |
    clonoSEQ
    |
    cyclophosphamide • Orca-T • firicabtagene autoleucel (CRG-022)
    1year
    Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=33, Recruiting, City of Hope Medical Center | Initiation date: Sep 2024 --> May 2024
    Trial initiation date
    |
    melphalan • fludarabine IV • thiotepa • Orca-T
    over1year
    Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (clinicaltrials.gov)
    P1, N=255, Active, not recruiting, Orca Biosystems, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    Orca-T
    over1year
    Precision-T (PhIII component): Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (clinicaltrials.gov)
    P3, N=174, Active, not recruiting, Orca Biosystems, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    Orca-T
    over1year
    Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=33, Recruiting, City of Hope Medical Center | Initiation date: Mar 2024 --> Sep 2024
    Trial initiation date
    |
    melphalan • fludarabine IV • thiotepa • Orca-T
    over1year
    Precision-T (PhIb component): Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (clinicaltrials.gov)
    P1, N=255, Recruiting, Orca Biosystems, Inc. | Trial completion date: Apr 2028 --> Jul 2026
    Trial completion date • Metastases
    |
    Orca-T
    over1year
    Precision-T (PhIII component): Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (clinicaltrials.gov)
    P3, N=174, Recruiting, Orca Biosystems, Inc. | Trial completion date: Apr 2028 --> Apr 2027 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    Orca-T