Study of SG301 for Renal AMR After Transplantation

NCT07764627 | Not Yet Recruiting Phase 2

• 1 other identifier: CSG-301-204
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antibody Mediated Rejection

Outcome Measures

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

  Up to Week 52

Study Arms (1)

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.

Drug: SG301 Injection

Interventions

SG301 Injection DRUG

Dosage form: solution for infusion; Route of administration: intravenous; Frequency: weekly intervals (QW) for 4 weeks, then every 4 weeks (Q4W) for 48 weeks.

SG301 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;
• 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;
• 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;

Sponsors & Collaborators

• Hangzhou Sumgen Biotech Co., Ltd.: lead

Study Sites (1)

Shulan(Hang Zhou) Hospital

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Jing Yang

CONTACT

86-15210969106; yangjing@sumgenbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)