A Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of FR104, a Novel Antagonist Pegylated Anti-CD28 Fab' Antibody Fragment in de Novo Renal Transplant Patients

RC20_0007

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) of FR104 as well as its potential clinical effect on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.

2021-06-28

2024-03-01

2025-03-01

Active (not recruiting)

Early phase I

10

Inclusion Criteria: 1. Male or female ≥ 18 years old 2. Signed and dated written informed consent prior to any study procedure 3. First kidney transplantation 4. Willing and able to participate to the study 5. Women of childbearing potential must use appropriate method(s) of contraception during the clinical trial (oral contraception, implant or intrauterine device) throughout the study period and for 90 days after the last dose of FR104 6. Women of childbearing potential must have a negative urinary pregnancy test the day of transplantation 7. All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agree to no sperm donation until the end of the study, or for 90 days after the last dose of FR104, whichever is longer 8. Recipient of a kidney from deceased donor - 9. Recipient of a de novo kidney transplant able to start the immunosuppressive regimen at the protocol-specified time point 10. Recipients of a kidney with a cold ischemia time \< 36 hours 11. Patients with French social security Exclusion Criteria: 1. Recipient of a kidney from living donor 2. Patient at high immunological risk of rejection as determined for assessment of anti-donor reactivity: High TGI \>20% or Presence of pre-formed DSA with MFI\>500 (results 12 weeks prior to enrollment are acceptable if no blood transfusion or abortion occurred during this period) 3. Any retransplantation and combined transplantations 4. ABO incompatible transplantation 5. HIV-positive, EBV-negative or suffering active viral hepatitis B (AgHbs positive excluded) or hepatitis C, syphilis serology- positive recipient 6. CMV negative recipients of CMV positive donors (R-D+) 7. Patient with known history of tuberculosis 8. Uncontrolled concomitant infection or any other unstable medical condition (heart failure, severe liver disease, psychiatric disorders, substance abuse) that could interfere with the study objectives 9. A known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components 10. Previous history of cancer (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured) 11. Pregnant woman or likely to become pregnant or nursing 12. Patient under guardianship or trusteeship 13. Patient participating in another interventional clinical trial 14. Live viral or bacterial vaccines/treatment agents given from 3 months prior to FR104 administration (12 months for BCG vaccine)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2023-11-15