BridgeMD
A clinical trial applying Regulatory T cells in liver transplant recipients to investigate the safety and tolerability when stopping standard immunosuppression.
EU CTIS ID: 2023-508261-32-00
What this study is testing
Determine that autologous polyclonal ex-vivo expanded Tregs (Treg02) therapy in liver transplant recipients who are already receiving tacrolimus monotherapy is safe, well tolerated and modulates the immunologic response in the patient to enable permanent withdrawal of immunosuppression
- Phase I and Phase II (Integrated)- Other
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
- Adult patients (≥18 years of age) with end-stage liver disease who have had single liver transplant
- Willing and able to give signed and dated informed consent* for participation in the trial participate in the trial
- Negative SARS-CoV-2 test (depending on current recommendations)
- No evidence of marked abnormality in latest liver protocol biopsy around 1 year post LT or at inclusion
- >24 months, < 60 months from the date of liver transplantation
- Stable liver function as determined by clinical studies; direct bilirubin (< 17.1 µmol/l or 1 mg/dl, total bilirubin < 2.2 mg/dl, albumin > 3 g/l and ALT < 62 IU/l (< 2 ULN).
You likely can't join if
- Patient has previously received any tissue or organ transplant other than single liver transplant
- HCV-RNA serum positive, HIV positive, HBV surface antigen or HBV-DNA detected in serum at the day of inclusion into the trial
- Ongoing treatment with systemic immunosuppressive drugs other than tacrolimus at study entry
- Malignant or pre-malignant haematological conditions. Multiple myeloma, light or heavy chain deposition disease
- Participation in another clinical trial during the study or within 5 times as the half-life time of the drug used in the previous trial prior to planned study entry
- Known allergy/hypersensitivity to any component of the study product
See the full eligibility criteria
- Adult patients (≥18 years of age) with end-stage liver disease who have had single liver transplant
- Willing and able to give signed and dated informed consent* for participation in the trial participate in the trial
- Negative SARS-CoV-2 test (depending on current recommendations)
- No evidence of marked abnormality in latest liver protocol biopsy around 1 year post LT or at inclusion
- >24 months, < 60 months from the date of liver transplantation
- Stable liver function as determined by clinical studies; direct bilirubin (< 17.1 µmol/l or 1 mg/dl, total bilirubin < 2.2 mg/dl, albumin > 3 g/l and ALT < 62 IU/l (< 2 ULN).
- Inflammation grade < 4 and fibrosis stage < 3 in accordance with grading and staging recommendations
- RAI < 3 at the last biopsy or at inclusion
- At least 6 months stable on tacrolimus monotherapy with target trough levels of 5 ng/ml without complications
- No evidence of hepatic autoimmune disease (primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis)
- Haematology: Hb ≥ 7.0 g/dl; platelets ≥ 80x10^9/l; total leukocyte count: ≥ 3.0x10^9/l
- In the investigator’s opinion, is able and willing to comply with all the trial requirements
- Patient has previously received any tissue or organ transplant other than single liver transplant
- HCV-RNA serum positive, HIV positive, HBV surface antigen or HBV-DNA detected in serum at the day of inclusion into the trial
- Ongoing treatment with systemic immunosuppressive drugs other than tacrolimus at study entry
- Malignant or pre-malignant haematological conditions. Multiple myeloma, light or heavy chain deposition disease
- Participation in another clinical trial during the study or within 5 times as the half-life time of the drug used in the previous trial prior to planned study entry
- Known allergy/hypersensitivity to any component of the study product
- Known contraindication to the protocol-specified treatments / medications
- Liver transplant dysfunction defined as fibrosis stage >3, Albumin <3 g/l and ALT >62 IU/l (>2 ULN)
- Severe irreversible obstructive or restrictive lung disease
- Previous treatment with any desensitization procedure with or without intravenous immunoglobulin
- HCC patients with high risk of recurrence as defined >G1/2, >L0, >V0 and > unifocal as defined by Edmondson-Steiner HCC grading scheme
- Concomitant malignancy or history of malignancy prior to study inclusion in the trial (excluding successfully treated non-metastatic basal/squamous cell carcinoma of the skin, successfully embolized HCC)
- Active or systemic immune disease that precludes discontinuation of immunosuppression
- Evidence of significant local or systemic infection
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.