Antibody Mediated RejectionPhase 2NCT07764627
Study of SG301 for Renal AMR After Transplantation
A Phase 2 study testing SG301 Injection in people with Antibody Mediated Rejection, run by Hangzhou Sumgen Biotech Co., Ltd. at 7 sites in China.
Trial summary
To evaluate the safety and tolerability of SG301 injection in patients with antibody-mediated rejection (AMR) after renal transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antibody Mediated Rejection
- What is being tested?
- SG301 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 7 sitesChina
- Study dates
- 1 Sep 2026to 30 Jun 2028
- 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
- Voluntarily sign the written informed consent form;
- Age ≥18 and ≤75 years;
- Expected survival ≥3 months;
- ≥180 days after renal transplantation, with stable graft function (from living or deceased donor);
- Biopsy-confirmed active or chronic active AMR (with or without peritubular capillary C4d deposition), per Banff 2022 classification;
- DSA: within 6 months prior to first dose, donor specific antibodies (DSA) specific to HLA class I and/or II antigens (pre existing and/or de novo) confirmed by local laboratory and meeting the local laboratory's positive definition;
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- Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m² at screening (CKD EPI formula);
- Recovery from adverse events due to prior treatment to ≤ Grade 1 (CTCAE v6.0), except for toxicities such as alopecia that are judged by the investigator to have no safety risk and not to violate other inclusion/exclusion criteria;
- Female participants of childbearing potential or male participants whose partners are of childbearing potential must remain abstinent or use reliable contraceptive measures during the study treatment period and for at least 6 months after the last dose of SG301. Male participants must refrain from sperm donation during the study and for at least 6 months after the last dose.
Who cannot join
- Concomitant T cell-mediated rejection (TCMR);
- New-onset or recurrent severe thrombotic microangiopathy; polyomavirus nephropathy; new-onset or recurrent glomerulonephritis;
- Prior treatment with other anti-CD38 monoclonal antibodies;
- Use of other monoclonal/polyclonal antibody immunosuppressive agents within 3 months prior to the first dose of study drug;
- Latent or active tuberculosis, or active viral (HBV, HCV, HIV, CMV), bacterial, or fungal infection requiring systemic therapy, or other active infections requiring systemic treatment;
- Active malignancy that makes the patient unsuitable for immunosuppressive therapy;
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- Presence of serious medical or psychiatric illness that may interfere with the smooth conduct of the study;
- Prior multi-organ transplantation (including en bloc or dual kidney transplantation);
- Acute, rapid decline in renal function such that, in the investigator's judgement, the participant is likely to require renal replacement therapy within the subsequent 30 days;
- Receipt of any of the following treatments for AMR or TCMR within 3 months prior to the first dose of study drug (with the exception of glucocorticoids):
- Intravenous or subcutaneous immunoglobulin (IVIg/SCIg), plasma exchange, or immunoadsorption (antibody-depleting therapies);
- Complement system inhibitors (e.g., eculizumab);
- Proteasome inhibitors (e.g., bortezomib);
- Tocilizumab;
- Other investigational drugs within 3 months or 5 half-lives (whichever is longer) prior to start of study treatment;
- Female participants who are pregnant or breastfeeding;
- Other conditions that, in the investigator's judgement, would make the participant unsuitable for participation in the study.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
West China Hospital，Sichuan University
Chengdu, Sichuan, 610044
Yunying Shi, Doctor
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510062
Changxi Wang, Doctor
Shulan(Hang Zhou) Hospital
Hangzhou, Zhejiang
Zhangfei Shou, Doctor
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250012
Jianning Wang, Doctor
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530006
Xiyong Sun, Doctor
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Wenjun Shang, Doctor
About this study
Official title: A Phase II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG301 Injection in Patients With Antibody-Mediated Rejection (AMR) After Renal Transplantation
To evaluate the safety and tolerability of SG301 injection in patients with antibody-mediated rejection (AMR) after renal transplantation.
Read the detailed description
This study is a prospective, single arm, open label Phase II clinical trial enrolling patients with antibody mediated rejection (AMR) after renal transplantation. It aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SG301 injection in this patient population, and to obtain preliminary efficacy signals through renal biopsy at Week 25 (assessed per Banff 2022 criteria) and changes in donor specific antibody (DSA) levels, among other measures.
- Conditions
- Antibody Mediated Rejection
- Being tested
- SG301 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG301 InjectionDrug
Dosage form: solution for infusion; Route of administration: intravenous; Frequency: weekly intervals (QW) for 4 weeks, then every 4 weeks (Q4W) for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SG301 Injection | Experimental | This study uses a 28-day treatment cycle. In Cycle 1, SG301 is administered once weekly for 4 doses (QW×4); starting from Cycle 2, it is administered once per cycle (i.e., once every 4 weeks) for 12 doses (Q4W×12), totaling 16 doses. Receives: Drug: SG301 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety events
Number of participants experiencing study-specific safety events or meeting treatment stopping criteriaNumber of participants experiencing study-specific safety events or meeting treatment stopping criteria
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody Mediated RejectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT07764627
- Sponsor's protocol ID
- CSG-301-204
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 17 Aug 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG301 Injection in Patients With Antibody-Mediated Rejection (AMR) After Renal Transplantation
- ClinicalTrials.gov ID
- NCT07764627
- Acronym / sponsor ID
- CSG-301-204
- Conditions
- Antibody Mediated Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Aug 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.
To evaluate the safety and tolerability of SG301 injection in patients with antibody-mediated rejection (AMR) after renal transplantation.
Detailed description
This study is a prospective, single arm, open label Phase II clinical trial enrolling patients with antibody mediated rejection (AMR) after renal transplantation. It aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SG301 injection in this patient population, and to obtain preliminary efficacy signals through renal biopsy at Week 25 (assessed per Banff 2022 criteria) and changes in donor specific antibody (DSA) levels, among other measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SG301 Injection | Experimental | Drug: SG301 InjectionThis study uses a 28-day treatment cycle. In Cycle 1, SG301 is administered once weekly for 4 doses (QW×4); starting from Cycle 2, it is administered once per cycle (i.e., once every 4 weeks) for 12 doses (Q4W×12), totaling 16 doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign the written informed consent form;
- Age ≥18 and ≤75 years;
- Expected survival ≥3 months;
- ≥180 days after renal transplantation, with stable graft function (from living or deceased donor);
- Biopsy-confirmed active or chronic active AMR (with or without peritubular capillary C4d deposition), per Banff 2022 classification;
Key exclusion criteria (17 listed)
- Concomitant T cell-mediated rejection (TCMR);
- New-onset or recurrent severe thrombotic microangiopathy; polyomavirus nephropathy; new-onset or recurrent glomerulonephritis;
- Prior treatment with other anti-CD38 monoclonal antibodies;
- Use of other monoclonal/polyclonal antibody immunosuppressive agents within 3 months prior to the first dose of study drug;
- Latent or active tuberculosis, or active viral (HBV, HCV, HIV, CMV), bacterial, or fungal infection requiring systemic therapy, or other active infections requiring systemic treatment;
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 |
|---|---|---|
| SG301 InjectionDosage form: solution for infusion; Route of administration: intravenous; Frequency: weekly intervals (QW) for 4 weeks, then every 4 weeks (Q4W) for 48 weeks. | Drug | SG301 Injection |
Primary outcome
safety events
Time frame: Up to Week 52
Number of participants experiencing study-specific safety events or meeting treatment stopping criteriaNumber of participants experiencing study-specific safety events or meeting treatment stopping criteria
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 17 Aug 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.
7 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 SG301 Injection in people with Antibody Mediated Rejection, run by Hangzhou Sumgen Biotech Co., Ltd. at 7 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 9 inclusion and 17 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 Jing Yang (86-15210969106, yangjing@sumgenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety events (time frame: Up to Week 52). 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 17 Aug 2026.