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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SG301 Injection
DrugDosage form: solution for infusion; Route of administration: intravenous; Frequency: weekly intervals (QW) for 4 weeks, then every 4 weeks (Q4W) for 48 weeks.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: SG301 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to Week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: