Study of SG301 for Renal AMR After Transplantation
ConditionAntibody Mediated Rejection
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Sumgen Biotech Co., Ltd.
About this trial
To evaluate the safety and tolerability of SG301 injection in patients with antibody-mediated rejection (AMR) after renal transplantation.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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);
New-onset or recurrent severe thrombotic microangiopathy; polyomavirus nephropathy; new-onset or recurrent glomerulonephritis;
Prior treatment with other anti-CD38 monoclonal antibodies;
Trial design
Treatments tested in this trial
- SG301 Injection
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov