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A Phase 1 open-label trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of LAVA-1266, a CD123-targeting bispecific gamma delta-T cell engager, in patients with CD123 positive R/R AML and intermediate risk, high risk, or extremely high risk MDS

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Trial Profile

A Phase 1 open-label trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of LAVA-1266, a CD123-targeting bispecific gamma delta-T cell engager, in patients with CD123 positive R/R AML and intermediate risk, high risk, or extremely high risk MDS

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 28 Aug 2025

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At a glance

  • Drugs LAVA 1266 (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man
  • Sponsors Lava Therapeutics

Most Recent Events

  • 13 Aug 2025 Status changed to discontinued, according to a LAVA Therapeutics media release.
  • 13 Aug 2025 According to a LAVA Therapeutics media release, on 4 Aug 2025 company announced decision to discontinue its phase 1 clinical trial of LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome, and initiate the wind-down of the LAVA-1266 program.
  • 25 Feb 2025 According to a LAVA Therapeutics media release, the company will continue to enroll in the Phase 1 clinical study evaluating the safety and pharmacokinetics of LAVA-1266 in hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), and support its partnerships with Pfizer and Johnson and Johnson.

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