This is a case with metastatic gastric adenocarcinoma encountered severe hemolytic anemia during an early-phase clinical trial with a PD-1 and cytokine fusion bi-specific antibody. These events manifested as acute direct antiglobulin test (DAT) negative hemolytic anemia, necessitating prompt intervention. The administration of corticosteroid resulted in a complete resolution, enabling the patient to proceed with participation in a subsequent fifth-line therapy trial. The successful management of the adverse events underscores the significance of vigilant monitoring, timely diagnosis, and appropriate therapeutic strategies especially in the context of clinical trials with limited knowledge on safety. The patient’s positive response to prednisone not only addressed the DAT negative hemolytic anemia but also facilitated a seamless transition to another early-phase clinical trial.

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Autoimmune Hemolytic Anemia Post Immune Checkpoint Inhibitors

  • Blessie Elizabeth Nelson,
  • Thein Hlaing Oo,
  • Cristhiam Rojas-Hernandez

摘要

This is a case with metastatic gastric adenocarcinoma encountered severe hemolytic anemia during an early-phase clinical trial with a PD-1 and cytokine fusion bi-specific antibody. These events manifested as acute direct antiglobulin test (DAT) negative hemolytic anemia, necessitating prompt intervention. The administration of corticosteroid resulted in a complete resolution, enabling the patient to proceed with participation in a subsequent fifth-line therapy trial. The successful management of the adverse events underscores the significance of vigilant monitoring, timely diagnosis, and appropriate therapeutic strategies especially in the context of clinical trials with limited knowledge on safety. The patient’s positive response to prednisone not only addressed the DAT negative hemolytic anemia but also facilitated a seamless transition to another early-phase clinical trial.