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<p>CD19-negative relapse occurs in ~30% of persons with relapsed or refractory large B cell lymphoma (LBCL) who respond to axicabtagene ciloleucel (axi-cel; CD19-directed chimeric antigen receptor (CAR) T cell therapy). In this phase 2 single-arm study, 26 participants with chemorefractory LBCL received axi-cel in combination with rituximab. The primary endpoint was investigator-assessed complete response rate; select secondary endpoints included duration of response (DOR), axi-cel pharmacokinetics and safety. The complete response rate was 73%. Median DOR was 26.0 months; 46% of participants had an ongoing response at data cutoff. Peak CAR T cell (normalized by tumor burden) and rituximab area-under-the-curve levels were elevated in participants with complete or ongoing response. Axi-cel plus rituximab treatment led to durable responses with no new safety signals despite persistent B cell aplasia and pharmacokinetics of axi-cel were unaffected, indicating that dual targeting of CD19 and CD20 is a feasible and safe approach to potentially limit antigen escape. ClinicalTrials.gov registration: <a href="https://clinicaltrials.gov/ct2/show/NCT04002401">NCT04002401</a>.</p>

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Axicabtagene ciloleucel in combination with rituximab for refractory large B cell lymphoma: the phase 2, single-arm ZUMA-14 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月5日

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  • Paolo Strati,
  • Lori Leslie,
  • Parveen Shiraz,
  • Lihua E. Budde,
  • Olalekan O. Oluwole,
  • Matthew Ulrickson,
  • Aravind Ramakrishnan,
  • Teresa Zhang,
  • Jennifer Sun,
  • Francesca Milletti,
  • Justyna Kanska,
  • Rhine Shen,
  • Frank Neumann,
  • Hairong Xu,
  • Krish Patel

摘要

CD19-negative relapse occurs in ~30% of persons with relapsed or refractory large B cell lymphoma (LBCL) who respond to axicabtagene ciloleucel (axi-cel; CD19-directed chimeric antigen receptor (CAR) T cell therapy). In this phase 2 single-arm study, 26 participants with chemorefractory LBCL received axi-cel in combination with rituximab. The primary endpoint was investigator-assessed complete response rate; select secondary endpoints included duration of response (DOR), axi-cel pharmacokinetics and safety. The complete response rate was 73%. Median DOR was 26.0 months; 46% of participants had an ongoing response at data cutoff. Peak CAR T cell (normalized by tumor burden) and rituximab area-under-the-curve levels were elevated in participants with complete or ongoing response. Axi-cel plus rituximab treatment led to durable responses with no new safety signals despite persistent B cell aplasia and pharmacokinetics of axi-cel were unaffected, indicating that dual targeting of CD19 and CD20 is a feasible and safe approach to potentially limit antigen escape. ClinicalTrials.gov registration: NCT04002401.