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A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome

An Efficacy and Safety Study of AND017 for the Treatment of Anemia Due to Lower Risk Myelodysplastic Syndromes (MDS)

NCT06304103•Kind Pharmaceuticals LLC

Summary

This is a Phase 2, multicenter, randomized, open-lable, dose ranging study to evaluate the efficacy and safety of AND017 for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS) in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosed of primary myelodysplastic syndrome with a PISS-R grading of very low, low or intermediate risk and a bone marrow primitive cell count \< 5%, the time frame for this grading assessment should be at least 12 weeks prior to the first dose
•2. Non-5q(del)-associated myelodysplastic syndrome.
•3. Two non-transfused hemoglobin ≥ 6.0 g/dL and \< 10.0 g/dL, averaged over the screening period, at least one week and more apart, and with no more than 1.3 g/dL difference between the two Hb.
•4. Non-transfused subjects (NTD cohort) defined as no red blood cell transfusion in the 16 weeks prior to randomization or low transfusion load subjects defined as 3-7 pRBC units transfused in the 16 weeks prior to randomization and at least two different time points (LTB-1 cohort) or 1-2 pRBC units transfused at one time point in the 16 weeks prior to randomization ( LTB-2 cohort) (except in the case of transfusion for treatment of other comorbidities such as blood loss, surgery, etc.);
•5. Baseline EPO level ≤ 500 mU/mL
•6. Platelets ≥ 30,000 /mm3 and absolute neutrophil count ≥ 800/mm3
•7. Adequate liver function with:
•* Total bilirubin \<2 x upper limit of normal (ULN) (subjects with Gilbert's syndrome, i.e., unconjugated hyperbilirubinemia, have a total bilirubin \<3 x ULN)
•* Aspartate aminotransferase (AST) \<3 x ULN
•* Alanine aminotransferase (ALT) \<3×ULN

Exclusion Criteria

•1. Diagnosed of secondary myelodysplastic syndrome or concurrent anemia from a cause other than the primary myelodysplastic syndrome.
•2. Significant myelofibrosis (fibrosis ≥ 2+).
•3. Planned clearing chemotherapy or whole brain spinal cord radiotherapy during the study period.
•4. Previous diagnosis of MDS IPSS-R high or very high risk.
•5. Prior or planned hematopoietic stem cell transplant during the study period.
•6. Received granulocyte colony-stimulating factor (G-CSF), or thrombopoietin, or thrombopoietin receptor agonist therapy within 8 weeks prior to the first dose;
•7. Treatment with antithymocyte globulin, azacitidine, decitabine, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to the first dose.
•8. The presence of active infection or inflammatory disease requiring systemic anti-infective therapy, including concomitant autoimmune disease with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)
•9. Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.)
•10. Inability to take oral medications, or a history of gastrectomy, concomitant gastroparesis, or other conditions that may have an impact on the absorption of gastrointestinal medications (excluding gastric polyps or colonic polypectomy)
+8 more criteria

Locations (1)

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

March 14, 2025

Primary Completion Date

December 1, 2026

Completion Date

May 1, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Myelodysplastic Syndromes

Interventions

AND017

DRUG

Contacts

Yusha Zhu, MD, PhD

CONTACT

6467252552 yushazhu@kindpharmaceutical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome

Inclusion Criteria

Exclusion Criteria

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