MAGE-A4/MAGE-A8-targeted TCR-based bispecific T cell engager in recurrent and/or refractory solid tumors: a phase 1 trial - Summary - MDSpire

MAGE-A4/MAGE-A8-targeted TCR-based bispecific T cell engager in recurrent and/or refractory solid tumors: a phase 1 trial

  • By

  • Martin Wermke

  • Sebastian Ochsenreither

  • Dirk Jaeger

  • Heiko Becker

  • Annalen Bleckmann

  • Farastuk Bozorgmehr

  • Manik Chatterjee

  • Stefanie Groepper

  • Mathias Haenel

  • Judith S. Hecker

  • Max-Felix Häring

  • Daniel Heudobler

  • Norbert Hilf

  • Martin Hofmann

  • Meike Hutt

  • Andrea Mayer-Mokler

  • Sarah Missel

  • Manuel Ruh

  • Heiko Schuster

  • Olga Veremchuk

  • Moritz Kleemiss

  • Stefan Knop

  • Simon Laban

  • Martin Sebastian

  • Silvia Spoerl

  • Cedrik Michael Britten

  • Carsten Reinhardt

  • May 31, 2026

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Objective:

To evaluate the safety, tolerability, pharmacokinetics, and initial antitumor activity of IMA401 as monotherapy and in combination with pembrolizumab in patients with heavily pretreated, advanced solid tumors.

Key Findings:
  • The selected MAGE-A4/8 target peptide showed high presentation levels on tumor cells and minimal presence in normal tissues.
  • IMA401 demonstrated potent cytotoxic activity against tumor cells with minimal off-target effects in preclinical studies.
  • The study aimed to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of IMA401.
Interpretation:

Limitations:
  • The study is in early phases and results are preliminary.
  • Further exploration of safety and efficacy in larger cohorts is necessary.
Conclusion:

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