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SG301-SC Injection Safety Study in Subjects With Primary ITP Patients

13. juli 2026 opdateret af: Hangzhou Sumgen Biotech Co., Ltd.

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Safety and Efficacy of SG301 SC Injection in Patients With Primary Immune Thrombocytopenia

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective is to evaluate the safety and efficacy of SG301 SC Injection in participants with ITP, while the secondary objectives are to assess the pharmacokinetic, pharmacodynamic and immunogenicity profiles of SG301 SC Injection in ITP participants.

A total of 60 ITP participants are planned to be enrolled in this study and randomly assigned at a 1:1:1 ratio to the low dose group, high dose group and placebo group, with approximately 20 participants per group. All participants enrolled in this study may receive concomitant background therapies at stable doses for at least 4 weeks prior to the first study drug administration, and is expected to be maintained throughout the study period.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Rekruttering
        • Fujian Medical University Union Hospital
        • Kontakt:
    • Henan
      • Pingdingshan, Henan, Kina, 467000
        • Rekruttering
        • Pingdingshan First People's Hospital
        • Kontakt:
    • Shandong
      • Jining, Shandong, Kina, 272011
        • Rekruttering
        • Jining No.1 People's Hospital
        • Kontakt:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300020
        • Rekruttering
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
        • Kontakt:
        • Kontakt:
    • Zhejiang
      • Wenzhou, Zhejiang, Kina, 325000
        • Rekruttering
        • The First Affiliated Hospital of Wenzhou Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Aged 18-75 years, any gender.
  2. Voluntarily signed informed consent and able to comply with study procedures.
  3. Clinically diagnosed with primary immune thrombocytopenia (ITP) per 2019 ASH Guidelines, international consensus statements, or 2025 Chinese Guidelines for Adult ITP Diagnosis and Treatment; disease duration ≥ 3 months.
  4. Experienced treatment failure or relapse after prior first-line therapy (glucocorticoids and/or IVIG).
  5. ≥2 platelet assessments ≥3 days apart before first dosing: mean platelet count <30×10⁹/L, no single value >35×10⁹/L.
  6. ECOG performance status 0-2.
  7. On stable-dose maintenance therapy for ≥4 weeks pre-first dose, with stability expected throughout the trial.

  8. Screening lab parameters meeting criteria below:

    1. Liver function: AST and ALT ≤3×ULN; total bilirubin ≤1.5×ULN.
    2. Renal function: eGFR ≥30 mL/min (CKD-EPI equation).
    3. CBC (no RBC transfusions, IL-11, EPO or colony-stimulating factors within 2 weeks before testing): hemoglobin ≥90 g/L, absolute neutrophil count ≥1.5×10⁹/L.
  9. Participants or partners with childbearing potential must use effective contraception during the study and for 6 months after last study drug administration.

Exclusion Criteria:

  1. Prior treatment targeting CD38, including but not limited to monoclonal antibodies, bispecific antibodies and antibody-drug conjugates.
  2. Secondary thrombocytopenia or concurrent autoimmune hemolytic anemia.
  3. History of thromboembolism within 12 months prior to randomization, or severe bleeding events (hemoptysis, massive gastrointestinal hemorrhage, intracranial hemorrhage, etc.).
  4. Anticoagulants or antiplatelet agents (e.g., aspirin) administered within 4 weeks before randomization.
  5. Emergency ITP therapies (methylprednisolone, platelet transfusion, IVIG, TPO-RA, etc.) received within 4 weeks before randomization.
  6. Oral immunosuppressants other than azathioprine, cyclosporine A and mycophenolate mofetil (e.g., tacrolimus, sirolimus) within 4 weeks pre-randomization; anti-CD20 mAbs (e.g., rituximab) within 3 months pre-randomization.
  7. Splenectomy performed within 6 months before randomization.
  8. Diagnosis of myelodysplastic syndrome; history of malignancy within 5 years pre-randomization (excluding cervical carcinoma in situ, basal cell skin carcinoma, etc.).
  9. Participation in another clinical trial within 4 weeks or 5 half-lives pre-randomization (whichever is longer), except placebo-controlled trials.
  10. History of severe recurrent or chronic infection; active systemic infection requiring IV antibiotics, antivirals, antiparasitics or antifungals within 4 weeks pre-randomization (excluding prophylaxis); acute infection; superficial skin infection within 1 week pre-randomization.
  11. Major surgery within 12 weeks pre-randomization, unhealed wounds, ulcers or fractures, or planned major surgery during the study.
  12. Severe cardiovascular or cerebrovascular diseases, including but not limited to: myocardial infarction, unstable angina or stroke within 6 months pre-randomization; NYHA Class III/IV heart failure; screening QTcF >480 ms or familial long QT syndrome; uncontrolled hypertension (resting SBP ≥160 mmHg and/or DBP ≥95 mmHg).
  13. HIV infection, active hepatitis B or hepatitis C.
  14. Confirmed active syphilis or Mycobacterium tuberculosis infection.
  15. Known hypersensitivity to monoclonal antibodies (prior Grade ≥3 allergic reactions per CTCAE v6.0) or excipients of investigational product.
  16. Live or attenuated live vaccines administered within 4 weeks pre-randomization or planned during the study.
  17. History of solid organ transplantation (heart, lung, kidney, liver, etc.) or hematopoietic stem cell/bone marrow transplantation.
  18. Lactating females.
  19. Any condition judged by the investigator to interfere with subject compliance or trial participation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SG301 SC Injection-low dose group
SG-301 SC monotherapy Weekly dosing for 8 doses
Medicin: SG301 SC monotherapy low dose group
SG301 SC weekly for a total of 8 doses
Eksperimentel: SG301 SC Injection-high dose group
SG-301 SC monotherapy Weekly dosing for 8 doses
Medicin: SG301 SCmonotherapy high dose group
SG301 SC weekly for a total of 8 doses
Placebo komparator: SG301 SC Placebo
Placebo SC monotherapy Weekly dosing for 8 doses
Medicin: Placebo group
SG301 SC Placebo weekly for a total of 8 doses.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Treatment-Emergent Adverse Events
Tidsramme: up to 24 weeks
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6
up to 24 weeks
ORR
Tidsramme: at Week 8 of treatment
Overall platelet response rate
at Week 8 of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hangzhou Sumgen Biotech Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. juni 2026

Primær færdiggørelse (Anslået)

17. maj 2027

Studieafslutning (Anslået)

17. maj 2027

Datoer for studieregistrering

Først indsendt

9. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSG-301 SC-206

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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