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

3 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Rekrytering
        • Fujian Medical University Union Hospital
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Har inte rekryterat ännu
        • Nanfang Hospital, Southern Medical University
        • Kontakt:
    • Guangxi
      • Liuzhou, Guangxi, Kina, 545006
        • Har inte rekryterat ännu
        • Liuzhou People's Hospital
        • Kontakt:
      • Yulin, Guangxi, Kina, 537000
        • Rekrytering
        • Yulin Red Cross Hospital
        • Kontakt:
    • Hebei
      • Baoding, Hebei, Kina, 071000
        • Har inte rekryterat ännu
        • Hebei University Affiliated Hospital
        • Kontakt:
      • Chengde, Hebei, Kina, 067000
        • Har inte rekryterat ännu
        • Affiliated Hospital of Chengde Medical University
        • Kontakt:
      • Tangshan, Hebei, Kina, 063000
        • Rekrytering
        • North China University of Science and Technology Affiliated Hospital
        • Kontakt:
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150086
        • Rekrytering
        • The Second Affiliated Hospital of Harbin Medical University
        • Kontakt:
        • Kontakt:
    • Henan
      • Pingdingshan, Henan, Kina, 467000
        • Rekrytering
        • Pingdingshan First People's Hospital
        • Kontakt:
      • Zhenzhou, Henan, Kina, 450003
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Har inte rekryterat ännu
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:
      • Xiangyang, Hubei, Kina, 441021
        • Har inte rekryterat ännu
        • Xiangyang Central Hospital
        • Kontakt:
    • Jilin
      • Siping, Jilin, Kina, 136000
        • Rekrytering
        • Siping Central People's Hospital
        • Kontakt:
    • Shandong
      • Jinan, Shandong, Kina, 250014
        • Rekrytering
        • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
        • Kontakt:
      • Jining, Shandong, Kina, 272011
        • Rekrytering
        • Jining No.1 People's Hospital
        • Kontakt:
    • Shanxi
      • Changzhi, Shanxi, Kina, 046000
        • Rekrytering
        • Heping Hospital Affiliated to Changzhi Medical College
        • Kontakt:
      • Xian, Shanxi, Kina, China
        • Rekrytering
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Kontakt:
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Har inte rekryterat ännu
        • West China Hospital, Sichuan University
        • Kontakt:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300020
        • Rekrytering
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
        • Kontakt:
        • Kontakt:
    • Yunnan
      • Kunming, Yunnan, Kina, 650032
        • Rekrytering
        • Yunnan Provincial First People's Hospital
        • Kontakt:
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • Rekrytering
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Kontakt:
      • Wenzhou, Zhejiang, Kina, 325000
        • Rekrytering
        • The First Affiliated Hospital of Wenzhou Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: SG301 SC Injection-low dose group
SG-301 SC monotherapy Weekly dosing for 8 doses
Läkemedel: low dose group
SG301 SC weekly for a total of 8 doses, subcutaneous injection
Experimentell: SG301 SC Injection-high dose group
SG-301 SC monotherapy Weekly dosing for 8 doses
Läkemedel: high dose group
SG301 SC weekly for a total of 8 doses , subcutaneous injection
Placebo-jämförare: SG301 SC Placebo
Placebo SC monotherapy Weekly dosing for 8 doses
Läkemedel: Placebo group
SG301 SC Placebo weekly for a total of 8 doses, subcutaneous injection

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hangzhou Sumgen Biotech Co., Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 juni 2026

Primärt slutförande (Beräknad)

17 maj 2027

Avslutad studie (Beräknad)

17 maj 2027

Studieregistreringsdatum

Först inskickad

9 juli 2026

Först inskickad som uppfyllde QC-kriterierna

13 juli 2026

Första postat (Faktisk)

17 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CSG-301 SC-206

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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