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A study to investigate whether treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.
EU CTIS ID: 2023-508397-29-00
What this study is testing
To investigate whether a siplizumab-based regimen can induce allogeneic tolerance in deceased donor liver transplant recipients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Recipients are able to understand the study requirements and provide written informed consent before any study assessment performed.
- Male or female aged 18-70 receiving an ABO compatible deceased donor liver transplant.
- Model for end-stage liver disease (MELD) score <30 on recent evaluation within 60 days of screening
- Stable cardio-pulmonary status per the judgement of the investigator and eligible for transplantation per local regulations.
- Epstein-Barr virus (EBV) sero-positive.
- Male subjects must agree to maintain barrier contraception (condom) and further agree not to father a child for at least 4 months after the last dose of cyclophosphamide and 3 months after the last dose of mycophenolate mofetil (MMF).
You likely can't join if
- Use of other investigational drugs (or enrollment in another investigational drug study) within 30 days of screening or 5 half-lives of the medication, whichever is longer
- Subjects with extrahepatic malignancy or history of same, other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Cardiac ejection fraction ≤ 40% within 6 months or clinical evidence of cardiac insufficiency
- Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirement outlined in the protocol.
- Subjects with any other clinically significant medical condition or laboratory abnormality that would, in the judgment of the investigator interfere with the subject's ability to participate in the study
- Subjects who have received any live-attenuated vaccine within 2 months of planned transplant.
See the full eligibility criteria
Who can join
- Recipients are able to understand the study requirements and provide written informed consent before any study assessment performed.
- Male or female aged 18-70 receiving an ABO compatible deceased donor liver transplant.
- Model for end-stage liver disease (MELD) score <30 on recent evaluation within 60 days of screening
- Stable cardio-pulmonary status per the judgement of the investigator and eligible for transplantation per local regulations.
- Epstein-Barr virus (EBV) sero-positive.
- Male subjects must agree to maintain barrier contraception (condom) and further agree not to father a child for at least 4 months after the last dose of cyclophosphamide and 3 months after the last dose of mycophenolate mofetil (MMF).
- Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must agree to use highly effective methods of contraception during dosing and for at least 12 months after the last dose of cyclophosphamide.
What rules you out
- Use of other investigational drugs (or enrollment in another investigational drug study) within 30 days of screening or 5 half-lives of the medication, whichever is longer
- Subjects with extrahepatic malignancy or history of same, other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Cardiac ejection fraction ≤ 40% within 6 months or clinical evidence of cardiac insufficiency
- Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirement outlined in the protocol.
- Subjects with any other clinically significant medical condition or laboratory abnormality that would, in the judgment of the investigator interfere with the subject's ability to participate in the study
- Subjects who have received any live-attenuated vaccine within 2 months of planned transplant.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
- History of hypersensitivity to any of the study treatments or their excipients or to drugs of similar chemical classes (e.g., siplizumab, tacrolimus (TAC), cyclophosphamide or MMF)
- End stage liver disease of autoimmune origin, including autoimmune hepatitis, primary biliary cholangitis or primary sclerosing cholangitis.
- Subjects with leukopenia (WBC ≤2,000/mm3) or thrombocytopenia (platelet count < 70,000/mm3) at baseline
- Sero-positive for human immunodeficiency virus-1 (HIV-1) or hepatitis B surface antigen (HBsAg). Subjects who are sero-positive for Hepatitis C (HCV)virus are excluded without proof of sustained viral response (SVR) after anti-HCV treatment
- Subjects with a history of tuberculosis (TB) or latent TB infection as detected by Quantiferon Gold Plus interferon-gamma release assay (IGRA) (or current standard interferon gamma release assay for TB)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.