Primary Immune ThrombocytopeniaPhase 2NCT07710248
SG301-SC Injection Safety Study in Subjects With Primary ITP Patients
A Phase 2 study testing low dose group and high dose group in people with Primary Immune Thrombocytopenia, run by Hangzhou Sumgen Biotech Co., Ltd. at 22 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- low dose group and high dose group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 22 sitesChina
- Study dates
- 11 Jun 2026to 17 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, any gender.
- Voluntarily signed informed consent and able to comply with study procedures.
- 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.
- Experienced treatment failure or relapse after prior first-line therapy (glucocorticoids and/or IVIG).
- ≥2 platelet assessments ≥3 days apart before first dosing: mean platelet count <30×10⁹/L, no single value >35×10⁹/L.
- ECOG performance status 0-2.
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- On stable-dose maintenance therapy for ≥4 weeks pre-first dose, with stability expected throughout the trial.
- Screening lab parameters meeting criteria below:
- Liver function: AST and ALT ≤3×ULN; total bilirubin ≤1.5×ULN.
- Renal function: eGFR ≥30 mL/min (CKD-EPI equation).
- 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.
- Participants or partners with childbearing potential must use effective contraception during the study and for 6 months after last study drug administration.
Who cannot join
- Prior treatment targeting CD38, including but not limited to monoclonal antibodies, bispecific antibodies and antibody-drug conjugates.
- Secondary thrombocytopenia or concurrent autoimmune hemolytic anemia.
- History of thromboembolism within 12 months prior to randomization, or severe bleeding events (hemoptysis, massive gastrointestinal hemorrhage, intracranial hemorrhage, etc.).
- Anticoagulants or antiplatelet agents (e.g., aspirin) administered within 4 weeks before randomization.
- Emergency ITP therapies (methylprednisolone, platelet transfusion, IVIG, TPO-RA, etc.) received within 4 weeks before randomization.
- 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.
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- Splenectomy performed within 6 months before randomization.
- Diagnosis of myelodysplastic syndrome; history of malignancy within 5 years pre-randomization (excluding cervical carcinoma in situ, basal cell skin carcinoma, etc.).
- Participation in another clinical trial within 4 weeks or 5 half-lives pre-randomization (whichever is longer), except placebo-controlled trials.
- 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.
- Major surgery within 12 weeks pre-randomization, unhealed wounds, ulcers or fractures, or planned major surgery during the study.
- 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).
- HIV infection, active hepatitis B or hepatitis C.
- Confirmed active syphilis or Mycobacterium tuberculosis infection.
- Known hypersensitivity to monoclonal antibodies (prior Grade ≥3 allergic reactions per CTCAE v6.0) or excipients of investigational product.
- Live or attenuated live vaccines administered within 4 weeks pre-randomization or planned during the study.
- History of solid organ transplantation (heart, lung, kidney, liver, etc.) or hematopoietic stem cell/bone marrow transplantation.
- Lactating females.
- Any condition judged by the investigator to interfere with subject compliance or trial participation.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Not yet recruiting
Hebei University Affiliated Hospital
Baoding, Hebei, 071000
Hua Xue, Doctor, xh-xuehua@163.com
- Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000
Xuliang Shen, shenxlcyp@sohu.com
- Not yet recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000
Zhihua Zhang, zzhangzhihua@163.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jinrong Yang, gongyuping@hotmail.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fenge Yang, Doctor, 339694677@qq.com
- Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jieyu Ye, jieyu_ye@163.com
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Hongyan Tong, hongyantong@aliyun.com
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Zhengning Wang, josieon826@sina.cn
Wei Wang, ww0543@163.com
- Recruiting
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan, Shandong, 250014
Yan Shi, shiyansjj@163.com
- Recruiting
Jining No.1 People's Hospital
Jining, Shandong, 272011
Yuan Xu, Doctor, likai0111@163.com
- Recruiting
Yunnan Provincial First People's Hospital
Kunming, Yunnan, 650032
Zhengfa Li, lizf2002@sina.com
- Not yet recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Qiangqiang Zhao, zgxyws@163.com
- Recruiting
Pingdingshan First People's Hospital
Pingdingshan, Henan, 467000
Zhanfang Wang, Doctor, WZF3922031@163.com
- Recruiting
Siping Central People's Hospital
Siping, Jilin, 136000
Yajuan Li, ilwxtk@163.com
- Recruiting
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000
Zhenyu Yan, hbyzy2011@163.com
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Lei Zhang, Doctor, 86-022-23608031, zlpumc@hotmail.com
Yunfei Chen, Doctor, 86-022-23608031, zlpumc@hotmail.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Songfu Jiang, Doctor, Jiangsongfu@189.cn
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heng Mei, hmei@hust.edu.cn
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, China
Wanhong Zhao, 13991365406@163.com
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Guolin Yuan, yuanguo1973@163.com
- Recruiting
Yulin Red Cross Hospital
Yulin, Guangxi, 537000
Zhao Lv, 371535062@qq.com
- Not yet recruiting
Henan Cancer Hospital
Zhenzhou, Henan, 450003
Hu Zhou, Doctor, tigerzhoupumc@163.com
About this study
Official title: 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.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- low dose group, high dose group, Placebo group
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose groupDrug
SG301 SC weekly for a total of 8 doses, subcutaneous injection
high dose groupDrug
SG301 SC weekly for a total of 8 doses , subcutaneous injection
Placebo groupDrug
SG301 SC Placebo weekly for a total of 8 doses, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SG301 SC Injection-low dose group | Experimental | SG-301 SC monotherapy Weekly dosing for 8 doses Receives: Drug: low dose group |
| SG301 SC Injection-high dose group | Experimental | SG-301 SC monotherapy Weekly dosing for 8 doses Receives: Drug: high dose group |
| SG301 SC Placebo | Placebo comparator | Placebo SC monotherapy Weekly dosing for 8 doses Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6
Measured: up to 24 weeks
ORR
Overall platelet response rate
Measured: at Week 8 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start11 Jun 2026
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710248
- Sponsor's protocol ID
- CSG-301 SC-206
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07710248
- Acronym / sponsor ID
- CSG-301 SC-206
- Conditions
- Primary Immune Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SG301 SC Injection-low dose group | Experimental | Drug: low dose groupSG-301 SC monotherapy Weekly dosing for 8 doses |
| SG301 SC Injection-high dose group | Experimental | Drug: high dose groupSG-301 SC monotherapy Weekly dosing for 8 doses |
| SG301 SC Placebo | Placebo comparator | Drug: Placebo groupPlacebo SC monotherapy Weekly dosing for 8 doses |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18-75 years, any gender.
- Voluntarily signed informed consent and able to comply with study procedures.
- 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.
- Experienced treatment failure or relapse after prior first-line therapy (glucocorticoids and/or IVIG).
- ≥2 platelet assessments ≥3 days apart before first dosing: mean platelet count <30×10⁹/L, no single value >35×10⁹/L.
Key exclusion criteria (19 listed)
- Prior treatment targeting CD38, including but not limited to monoclonal antibodies, bispecific antibodies and antibody-drug conjugates.
- Secondary thrombocytopenia or concurrent autoimmune hemolytic anemia.
- History of thromboembolism within 12 months prior to randomization, or severe bleeding events (hemoptysis, massive gastrointestinal hemorrhage, intracranial hemorrhage, etc.).
- Anticoagulants or antiplatelet agents (e.g., aspirin) administered within 4 weeks before randomization.
- Emergency ITP therapies (methylprednisolone, platelet transfusion, IVIG, TPO-RA, etc.) received within 4 weeks before randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose groupSG301 SC weekly for a total of 8 doses, subcutaneous injection | Drug | SG301 SC Injection-low dose group |
| high dose groupSG301 SC weekly for a total of 8 doses , subcutaneous injection | Drug | SG301 SC Injection-high dose group |
| Placebo groupSG301 SC Placebo weekly for a total of 8 doses, subcutaneous injection | Drug | SG301 SC Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 24 weeks
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6
ORR
Time frame: at Week 8 of treatment
Overall platelet response rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low dose group and high dose group in people with Primary Immune Thrombocytopenia, run by Hangzhou Sumgen Biotech Co., Ltd. at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Songping Ao (86-0571-86035537, aosongping@sumgenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.