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Clinical Trials in China / NCT06594965
Starting soon Phase 2

A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

NCT06594965 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 2
Started
2024-10-30
Last updated
2024-09-19

Condition(s) studied

Myelodysplastic SyndromesAnemiaMDSBone Marrow Disease

Investigational drug(s) / intervention(s)

HS-20106

HS-20106: HS-20106 administered subcutaneously every 4 weeks for up to 6 cycles. Eligible participants may be able to continue to receive subcutaneously administered HS-20106 after completing 6 cycles in the extended treatment period.

Study summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosis of MDS according to World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease(IPSS-R ≤ 3.5). 2. \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood. 3. Each cohort is defined as: Cohort 1: In NTD participants, having received no red blood cell (RBC) transfusions within 16 weeks Hgb concentration between 60 and 100g/L. Cohort 2: In LTB participants, having received an average of \< 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks/2) Hgb concentration between 60 and 100 g/L. In HTB participants, having received an average of ≥ 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks/2) Hgb concentration between 60 and 100 g/L. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia. 5. Females of child-bearing potential and sexually active males must agree to use effective methods of contraception. Exclusion Criteria: 1. Chromosome 5q deletion, del (5q). 2. Anemia caused by other reasons, such as iron deficiency anemia, megaloblastic anemia, aplastic anemia, renal anemia or blood loss. 3. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases). 4. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept. 5. Treatment within 4 weeks prior to C1D1 with: 1\) Erythropoiesis stimulating agent (ESA) OR 2) Granulocyte colony-stimulating factor (G-CSF) OR 3) Granulocyte-macrophage colony-stimulating factor (GM-CSF) 6. Iron chelation therapy if initiated within 8 weeks prior to C1D1. 7. Vitamin B12 therapy if initiated within 8 weeks prior to C1D1. 8. Treatment with another investigational drug or device or approved therapy for investigational use \< or = 4 weeks prior to C1D1, or if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer. 9\. Peripheral blood white blood cell count \>13.0 x 10\*9/L. 10. Neutrophil count \< 1.0 x 10\*9/L. 11. Platelet count \> 450 x 10\*9/L or \< 30 x 10\*9/L. 12. Transferrin saturation \< 15%. 13. Ferritin \< 15 μg/L. 14. Folate \< 4.5 nmol/L (\< 2.0 ng/mL). 15. Vitamin B12 \< 148 pmol/L (\< 200 pg/mL). 16. Estimated glomerular filtration rate (GFR) \< 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]. 17\. Pregnant or lactating females

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology and Blood Diseases Hospital Tianjin Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06594965 on ClinicalTrials.gov ↗ ← All trials in China