A phase 1 trial of HPV16 E7 T-cell receptor-engineered T cells in patients with relapsed/refractory HPV16-positive cancers (KITE-439 trial) - Summary - MDSpire

A phase 1 trial of HPV16 E7 T-cell receptor-engineered T cells in patients with relapsed/refractory HPV16-positive cancers (KITE-439 trial)

  • By

  • Kedar Kirtane

  • Jiaxin Niu

  • George Blumenschein

  • Erminia Massarelli

  • Glenn J. Hanna

  • Sylvia Lee

  • Michael R. Bishop

  • Gottfried E. Konecny

  • Daqin Mao

  • Yan Zheng

  • Katherine Rodriguez

  • Jenny J. Kim

  • Chad Williams

  • Colleen Schweitzer

  • Sabina Adhikary

  • A. Scott Jung

  • Christopher A. Klebanoff

  • May 21, 2026

  • 0 min

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Objective:

To evaluate the safety, tolerability, and efficacy of KITE-439, an autologous T-cell product expressing TCR specific for HPV16 E7 in patients with relapsed/refractory HPV16-positive epithelial cancers, with a primary endpoint of dose-limiting toxicities (DLTs).

Key Findings:
  • No dose-limiting toxicities (DLTs) were observed during the trial, indicating a favorable safety profile.
  • KITE-439 cells were detected in peripheral blood within 7 days post-infusion, suggesting effective engraftment.
  • Three patients experienced Grade 1–2 cytokine release syndrome, and four had Grade 1–2 neurologic events, all resolved quickly, highlighting manageable side effects.
  • One patient achieved a partial response, and seven had stable disease, indicating potential efficacy that warrants further investigation.
Interpretation:

KITE-439 demonstrates an acceptable safety profile and potential efficacy in treating patients with HPV-associated epithelial cancers, warranting further investigation to optimize treatment protocols.

Limitations:
  • Small sample size of only eight patients, limiting generalizability.
  • Short follow-up duration to assess long-term efficacy and safety, necessitating longer studies to confirm findings.
Conclusion:

KITE-439 shows promise as a treatment for r/r HPV16+ epithelial cancers, but further studies are needed to optimize T-cell characteristics and treatment protocols for enhanced antitumor activity.

Original Source(s)

A phase 1 trial of HPV16 E7 T-cell receptor-engineered T cells in patients with relapsed/refractory HPV16-positive cancers (KITE-439 trial)

  • by Kedar Kirtane, Jiaxin Niu, George Blumenschein, Erminia Massarelli, Glenn J. Hanna, Sylvia Lee, Michael R. Bishop, Gottfried E. Konecny, Daqin Mao, Yan Zheng, Katherine Rodriguez, Jenny J. Kim, Chad Williams, Colleen Schweitzer, Sabina Adhikary, A. Scott Jung, Christopher A. Klebanoff

  • May 21, 2026

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