131-I Apamistamab/CAR T-cell (Iomab-ACT) / Actinium 
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  • ||||||||||  Iomab-B (I-131-apamistamab) / Actinium, Immedica
    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 (Hall D (Ernest N. Morial Convention Center)) -  Nov 4, 2022 - Abstract #ASH2022ASH_6475;    
    P1
    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.