Herein, we present the phase 1a dose escalation data of IO-202 as monotherapy and in combination with azacitidine (AZA) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and R/R chronic myelomonocytic leukemia (CMML), and the phase 1b dose expansion data of IO-202 combined with AZA for the treatment of hypomethylating agent (HMA)-naïve CMML. Overall, the data support a future pivotal study of IO-202 + AZA in patients with HMA-naïve CMML. This trial was registered at www.clinicaltrials.gov as #NCT04372433.

P1, N=12, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Recruiting

P1, N=222, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed

P1, N=11, Completed, Peking University People's Hospital | Trial primary completion date: Dec 2023 --> Aug 2024 | Not yet recruiting --> Completed

P1, N=67, Completed, Immune-Onc Therapeutics | Active, not recruiting --> Completed | N=106 --> 67 | Trial completion date: Jan 2027 --> Jan 2025 | Trial primary completion date: Jan 2026 --> Jan 2025

P1, N=230, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Feb 2025 --> Jun 2025 | Trial primary completion date: Feb 2025 --> Jun 2025

P1, N=130, Active, not recruiting, NGM Biopharmaceuticals, Inc | Recruiting --> Active, not recruiting

P1, N=280, Recruiting, Biond Biologics | Not yet recruiting --> Recruiting

P1, N=106, Active, not recruiting, Immune-Onc Therapeutics | Recruiting --> Active, not recruiting

P1, N=22, Completed, Immune-Onc Therapeutics | Active, not recruiting --> Completed | N=200 --> 22

In conclusion, our study elucidates that LILRB4 is an ideal biomarker and promising immunotherapy target for high-risk MM. LILRB4-STAR-T cell immunotherapy is promising against tumor cells and immunosuppressive tumor microenvironment in MM.

P1, N=13, Completed, Presage Biosciences