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Experimental injection aims to boost platelets in chronic blood disorder

NCT ID NCT07710248

Disease control Sponsor: Hangzhou Sumgen Biotech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This Phase 2 trial tests an experimental drug called SG301, given as a weekly injection, for adults with primary immune thrombocytopenia (ITP) — a condition where the immune system destroys platelets, raising bleeding risk. The study includes about 60 people who have not improved with standard treatments. Participants receive either a low or high dose of SG301 or a placebo, and researchers track safety and whether platelet counts improve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental monoclonal antibody injection called SG301
What this could lead to
If successful, SG301 could offer a new treatment option for people with chronic ITP who have not responded to standard therapies.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not confirm effectiveness or safety. Side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura primary thrombocytopenia Purpura, Thrombocytopenic, Idiopathic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary immune thrombocytopenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Chengde Medical University

    NOT_YET_RECRUITING

    Chengde, Hebei, 067000, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Hebei University Affiliated Hospital

    NOT_YET_RECRUITING

    Baoding, Hebei, 071000, China

  • Henan Cancer Hospital

    NOT_YET_RECRUITING

    Zhenzhou, Henan, 450003, China

  • Heping Hospital Affiliated to Changzhi Medical College

    RECRUITING

    Changzhi, Shanxi, 046000, China

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Jining No.1 People's Hospital

    RECRUITING

    Jining, Shandong, 272011, China

  • Liuzhou People's Hospital

    NOT_YET_RECRUITING

    Liuzhou, Guangxi, 545006, China

  • Nanfang Hospital, Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510515, China

  • North China University of Science and Technology Affiliated Hospital

    RECRUITING

    Tangshan, Hebei, 063000, China

  • Pingdingshan First People's Hospital

    RECRUITING

    Pingdingshan, Henan, 467000, China

  • Siping Central People's Hospital

    RECRUITING

    Siping, Jilin, 136000, China

  • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)

    RECRUITING

    Jinan, Shandong, 250014, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The Second Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150086, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xian, Shanxi, China, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • Xiangyang Central Hospital

    NOT_YET_RECRUITING

    Xiangyang, Hubei, 441021, China

  • Yulin Red Cross Hospital

    RECRUITING

    Yulin, Guangxi, 537000, China

  • Yunnan Provincial First People's Hospital

    RECRUITING

    Kunming, Yunnan, 650032, China

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