Hypoxia-responsive CEA-targeted CAR T cells in CEA-positive solid tumors through intraperitoneal or intravenous infusion: a phase 1 trial - PubMed
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- #clinical trial
- #CAR T cell therapy
- #solid tumors
- Phase 1 trial evaluates hypoxia-responsive CEA-targeted CAR T cells (PC13) in CEA-positive solid tumors.
- 43 heavily pretreated participants received PC13 via intraperitoneal (I.P.) or intravenous (I.V.) infusion.
- Primary endpoint was safety; secondary endpoints included efficacy, pharmacokinetics, and pharmacodynamics.
- Grade 3 diarrhea occurred in 20.9% of participants; 76.7% experienced grade 1 or 2 cytokine release syndrome.
- Disease control rates: 82.4% (I.P.) and 68.0% (I.V.); objective response rates (ORRs): 23.5% (I.P.) and 8.0% (I.V.).
- Post hoc analyses showed higher ORRs in specific subgroups (e.g., 57.1% in I.P. group with peritoneal metastases).
- PC13 demonstrated manageable toxicity and promising efficacy, supporting further investigations.