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

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

NCT ID: NCT06594965

Condition: Myelodysplastic Syndromes
Anemia
MDS
Bone Marrow Disease

Conditions: Official terms:
Preleukemia
Anemia
Myelodysplastic Syndromes
Bone Marrow Diseases
Syndrome

Conditions: Keywords:
MDS
HS-20106
KER-050
fusion protein
TGF-β

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: HS-20106
Description: 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.
Arm group label: HS-20106 Cohort 1
Arm group label: HS-20106 Cohort 2

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.

Detailed description: Anemia is considered to be one of the most prevalent cytopenias in patients who have myelodysplastic syndromes, an umbrella term used to describe disorders relating to the ineffective production of red blood cells, white blood cells, and/or platelets. The goal of this study is to assess the efficacy, safety and PK of HS-20106 on anemia in Chinese patients with very low, low or intermediate risk MDS. Eligible subjects will be treated with HS-20106. Patients should be treated for at least 24 weeks in the core treatment period to assess their response to treatment.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institute of Hematology and Blood Diseases Hospital

Address:
City: Tianjin
Country: China

Start date: October 30, 2024

Completion date: October 30, 2026

Lead sponsor:
Agency: Hansoh BioMedical R&D Company
Agency class: Industry

Source: Hansoh BioMedical R&D Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06594965