^
    11ms
    MED20-165: Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=6, Recruiting, Memorial Sloan Kettering Cancer Center
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Iomab-ACT
    over1year
    MED20-165: Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=6, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Iomab-ACT
    2years
    An Ongoing Pilot Study of Targeted Radioimmunotherapy (131-I Apamistamab) Conditioning Prior to CD19-Targeted CAR T-Cell Therapy for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (ASH 2022)
    Within the last year alone, the FDA approved brexu-cel for adults w/ R/R B-ALL and expanded indications for liso-cel and axi-cel to include DLBCL w/ primary refractory disease or early first relapse...Anti-cytokine therapies beyond tocilizumab (anti-IL-6R mAb) are being investigated for prevention of CRS/ICANS, including lenzilumab (anti-GM-CSF mAb) and anakinra (IL-1R antagonist)...Accordingly, we designed and initiated a pilot study of Iomab-B w/ adoptive cellular therapy (Iomab-ACT; Fig 1A).Study design and Iomab-ACT is a single-institution pilot study of Iomab-B (w/o chemotherapy) as conditioning prior to 19-28z CAR-T in adults w/ R/R B-ALL or DLBCL (NCT04512716)...Unexpected toxicity (given low dose of ARC) observed in 1 pt included severe trilineage cytopenias lasting >8 wks (requiring RBC/PLT transfusion support, G-CSF, romiplostim) w/o marrow hypoplasia and w/o other apparent neoplastic or drug-induced etiology; this met criteria for dose-limiting toxicity and we will monitor in the next 3 pts...Key exploratory objectives include describing changes in circulating immune cells following ARC and 19-28z CAR T-cells w/spectral cytometry using a custom antibody panel (Fig 1B) and cytokine levels in cerebrospinal fluid. We hope to generate preliminary data to guide further study of CD45-targeted ARCs prior to CAR-T and other forms of adoptive cellular therapy.
    Clinical • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule) • CSF2 (Colony stimulating factor 2)
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Actemra IV (tocilizumab) • LENZ (lenzilumab) • Iomab-B (I-131-apamistamab) • Iomab-ACT • Kineret (anakinra) • Nplate (romiplostim)
    2years
    MED20-165: Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=6, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Iomab-ACT
    almost3years
    Iomab with Adoptive Cellular Therapy (Iomab-ACT): A Pilot Study of 131-I Apamistamab Followed By CD19-Targeted CAR T-Cell Therapy for Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (ASH 2021)
    However, following fludarabine/cyclophosphamide (Flu/Cy) conditioning and CAR T-cell therapy w/ a CD28 costimulatory domain (e.g. 19-28z CAR T-cells), rates of grade ≥3 ICANS and grade ≥3 cytokine release syndrome (CRS) in pts w/ R/R DLBCL and morphologic R/R B-ALL exceed 30%. If dose-limiting toxicity (severe infusion-related reactions, treatment-resistant severe CRS/ICANS, persistent regimen-related cytopenias, among others defined in protocol) is seen in 0-1 of the first 3 pts treated, then up to 6 total (up to 3 additional) pts will be treated. We have designed this study to provide preliminary data to support further investigation of CD45-targeted ARCs prior to adoptive cellular therapy.
    Clinical • CAR T-Cell Therapy • IO biomarker
    |
    CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • IL10 (Interleukin 10)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • Iomab-ACT
    over3years
    Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=6, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jan 2022 --> Jan 2023
    Clinical • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Iomab-ACT
    almost4years
    Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=6, Recruiting, Memorial Sloan Kettering Cancer Center | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • CAR T-Cell Therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Iomab-ACT
    almost4years
    Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Aug 2021 --> Jan 2022 | Initiation date: Oct 2020 --> Jan 2021 | Trial primary completion date: Aug 2021 --> Jan 2022
    Clinical • Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Iomab-ACT