Tests AK117 with azacitidine in higher-risk myelodysplastic syndromes
Tests AK117 plus azacitidine, or placebo, in adults with newly diagnosed higher-risk myelodysplastic syndromes.
Plain-language title generated from the registry record
Registry title: A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS) who have not been treated yet. They would get AK117 or placebo together with azacitidine.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed higher-risk MDS (2016 WHO classification) with less than 20% blasts in bone marrow or peripheral blood and an overall IPSS-R score of 3.5 or higher.
- Earlier treatment
- No earlier treatment with CD47 or SIRPα-targeting agents.
Main reasons for not taking part
- MDS that developed from an earlier myeloproliferative neoplasm (MPN) or MDS/MPN
- Earlier treatment with CD47 or SIRPα-targeting agents
- Another cancer with signs of remaining disease
- Known allergy to a study drug or severe reaction to other monoclonal antibodies
- Breastfeeding or planning to breastfeed during the study
Read by machine on 12 November 2026.
Where in China
- Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical collegeTianjin, ChinaContact: Zhijian XiaoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Akeso
- Trial code
- NCT06196203
- Record updated
- 11 February 2025
- Original description
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).
Inclusion: Age ≥ 18 years old at the time of enrolment; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Expected life expectancy ≥ 3 months; Newly diagnosed HR-MDS, according to the 2016 World Health Organization (WHO) classification with the presence of < 20% blasts in bone marrow or peripheral blood; Overall IPSS-R score ≥ 3.5; Ability to undergo the study-required bone marrow sample collection procedures; Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity); Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing; Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 180 days after the last dose of the study treatment; Unsterilized male patients having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until 180 days after the last dose of study treatment.
Exclusion: Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents; Patients who previously diagnosed with another malignancy and have any evidence of residual disease; Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies; Patients with any psychiatric or social factor which the investigator deems may interfere with the patient's ability to comply with the requirements of the study; Patients with current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy; Patients with known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders; Other conditions where the investigator considers the patient inappropriate for enrollment; MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplastic/myeloproliferative neoplasms (MDS/MPN); Concurrently participating in another interventional clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study; Patients who are breastfeeding or plans to breastfeed during the study.