OncoMatch/Clinical Trials/NCT07470762
Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Is NCT07470762 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including HS-10542 and HS-10542 for paroxysmal nocturnal hemoglobinuria.
Treatment: HS-10542 · HS-10542 · HS-10542 — This was a phase 1b/2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Demographics
Prior therapy
Must have received: C5 complement inhibitor (ikuzumab, covalimab) — stable use for first 6 months of random treatment
Stable use of C5 complement inhibitor ikuzumab/covalimab for the first 6 months of random treatment
Must have received: blood transfusion — at least one within last 4 months
Have at least one blood transfusion record within the last 4 months
Cannot have received: B-factor inhibitor
Exception: treatment duration of no more than one week and stopped for more than five half-lives before screening
Participants who have previously received B-factor inhibitor treatment, with a treatment duration of no more than one week and having stopped taking the drug for more than five half-lives before screening, may not be excluded
Lab requirements
Blood counts
reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L
Kidney function
severe kidney disease (eGFR<30 mL/min/1.73 m2, dialysis)
Liver function
ALT/ALP >3×ULN
Cardiac function
advanced heart disease (such as NYHA level IV); abnormal ECG: QTcF >450 msec for males and >470 msec for females; or other clinically significant abnormalities
Patients with laboratory evidence of bone marrow failure (reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L); advanced heart disease (such as NYHA level IV); abnormal ECG: The absolute value of QTcF (QT interval corrected by Fridericia 's formula > 450 msec for males and > 470 msec for females; or other clinically significant abnormalities as judged by the investigator. severe kidney disease (such as eGFR<30 mL/min/1.73 m2, dialysis), ALT/ALP>3×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07470762 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior B-factor inhibitor disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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