What type of study is this?

This is a Animal Study study (also classified as: Pre-Registered Trial).

What question did this study set out to answer?

To evaluate the efficacy and safety of ICT01 in combination with azacitidine-venetoclax in patients with newly diagnosed acute myeloid leukemia.

December 8, 2025Blood

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Phase 1/2 trial shows ICT01 enhanced efficacy with Aza-Ven in AML, suggesting favorable safety and outcomes.

To evaluate the efficacy and safety of ICT01 in combination with azacitidine-venetoclax in patients with newly diagnosed acute myeloid leukemia.
Randomized trial of ND-AML patients aged ≥75 years or unfit for intensive chemotherapy.
Patients received standard dosing of Aza-Ven plus ICT01 at either 10 mg or 75 mg.
Efficacy was measured as complete remission and CRc based on ELN 2022 guidelines.
Safety was assessed using NCI-CTCAE 5.0 and pharmacodynamics were analyzed in blood and bone marrow.
Of 57 patients, 54 were evaluable; 68% CR and 84% CRc achieved with ICT01LOW versus 44% CR and 69% CRc with ICT01HIGH (p=0.0006 and p=0.02).
9-month overall survival was 74% in the ICT01LOW cohort versus 56% in the ICT01HIGH cohort (HR 0.4; p=0.03).
Significant increase in baseline γ9δ2TC counts and serum IFNγ linked to better responses in ICT01-Aza-Ven treatment.

Péterlin et al. (2025) studied this question.

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