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<p>Chimeric antigen receptor (CAR) T cell therapy for solid tumors remains challenging. This phase 1, open-label, dose-escalation and expansion study (ClinicalTrials.gov registration: <a href="https://clinicaltrials.gov/ct2/show/NCT05396300">NCT05396300</a>) evaluated the safety and efficacy of PC13, a hypoxia-responsive, carcinoembryonic antigen (CEA)-targeted CAR T cell therapy, in persons with CEA-positive solid tumors. The primary endpoint was safety; secondary endpoints included efficacy, pharmacokinetics and pharmacodynamics. A total of 43 heavily pretreated participants (46.5% with ≥4 prior lines) were assigned to receive PC13 through intraperitoneal (I.P., <i>n</i> = 17) or intravenous (I.V., <i>n</i> = 26) infusion on the basis of predominant metastatic sites. Grade 3 diarrhea occurred in 20.9% of participants and 76.7% experienced grade 1 or 2 cytokine release syndrome. Disease control rates were 82.4% in the I.P. group and 68.0% in the I.V. group, with objective response rates (ORRs) of 23.5% and 8.0%, respectively. In post hoc analyses, ORRs reached 57.1% (4/7) in the I.P. group with peritoneal metastases and 40.0% (2/5) in the I.V. group without liver metastases, both among participants with CEA immunohistochemistry expression ≥ 90%. The predefined safety endpoint was met. PC13 demonstrated manageable toxicity and promising efficacy, supporting further investigations.</p>

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Hypoxia-responsive CEA-targeted CAR T cells in CEA-positive solid tumors through intraperitoneal or intravenous infusion: a phase 1 trial

  • 期刊论文

  • 发表日期：

    2026年2月27日

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  • Yang Gao,
  • Jie Li,
  • Hangyu Zhang,
  • Yingzi Zhang,
  • Siyuan Qian,
  • Xudong Zhu,
  • Libing Hong,
  • Li Xie,
  • Qihan Fu,
  • Xuanwen Bao,
  • Zhou Tong,
  • Yunyan Li,
  • Bin Li,
  • Linling Wang,
  • Junjie Shen,
  • Qianzhen Zhang,
  • Xiao He,
  • Yi Zheng,
  • Chao Yao,
  • Lulu Liu,
  • Peng Zhao,
  • Pedro Villarejo Campos,
  • Zhi Yang,
  • Cheng Qian,
  • Weijia Fang

摘要

Chimeric antigen receptor (CAR) T cell therapy for solid tumors remains challenging. This phase 1, open-label, dose-escalation and expansion study (ClinicalTrials.gov registration: NCT05396300) evaluated the safety and efficacy of PC13, a hypoxia-responsive, carcinoembryonic antigen (CEA)-targeted CAR T cell therapy, in persons with CEA-positive solid tumors. The primary endpoint was safety; secondary endpoints included efficacy, pharmacokinetics and pharmacodynamics. A total of 43 heavily pretreated participants (46.5% with ≥4 prior lines) were assigned to receive PC13 through intraperitoneal (I.P., n = 17) or intravenous (I.V., n = 26) infusion on the basis of predominant metastatic sites. Grade 3 diarrhea occurred in 20.9% of participants and 76.7% experienced grade 1 or 2 cytokine release syndrome. Disease control rates were 82.4% in the I.P. group and 68.0% in the I.V. group, with objective response rates (ORRs) of 23.5% and 8.0%, respectively. In post hoc analyses, ORRs reached 57.1% (4/7) in the I.P. group with peritoneal metastases and 40.0% (2/5) in the I.V. group without liver metastases, both among participants with CEA immunohistochemistry expression ≥ 90%. The predefined safety endpoint was met. PC13 demonstrated manageable toxicity and promising efficacy, supporting further investigations.