Antibody Mediated Rejection
Conditions
Brief summary
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.
Interventions
DRUGSG301 Injection
Dosage form: solution for infusion; Route of administration: intravenous; Frequency: weekly intervals (QW) for 4 weeks, then every 4 weeks (Q4W) for 48 weeks.
Sponsors
Hangzhou Sumgen Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the written informed consent form; 2. Age ≥18 and ≤75 years; 3. Expected survival ≥3 months; 4. ≥180 days after renal transplantation, with stable graft function (from living or deceased donor); 5. Biopsy-confirmed active or chronic active AMR (with or without peritubular capillary C4d deposition), per Banff 2022 classification; 6. 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; 7. Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m² at screening (CKD EPI formula); 8. 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
; 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety events | 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 |
Countries
China
Contacts
CONTACTJing Yang
Outcome results
None listed