Not Yet RecruitingPhase 2

Study of SG301 for Renal AMR After Transplantation

China10 participantsStarted 2026-09-01

Plain-language summary

To evaluate the safety and tolerability of SG301 injection in patients with antibody-mediated rejection (AMR) after renal transplantation.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m² at screening (CKD EPI formula);

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.
. Concomitant T cell-mediated rejection (TCMR);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

safety events

Timeframe: Up to Week 52

Trial details

NCT IDNCT07764627

SponsorHangzhou Sumgen Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Jing Yang

86-15210969106 yangjing@sumgenbio.com

View on ClinicalTrials.gov More Antibody Mediated Rejection trials