A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation

Phase 2

Active, not recruiting

• Conditions: Liver Transplantation
• Interventions: Biological: TCD601; Biological: Cyclophosphamide; Drug: TAC; Drug: MMF; Drug: Corticosteroids

• Registration Number: NCT06019507
• Lead Sponsor: ITB-Med LLC

Brief Summary

The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-29
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Able to understand the study requirements and provide written informed consent before and study assessment is performed
• Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant
• Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF

Exclusion Criteria

• Pregnant or nursing (lactating) women
• Subjects with a history of TB or latent TB infection
• Subjects with a history of cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	TCD601	TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
Arm 1	Cyclophosphamide	TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
Arm 1	TAC	TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
Arm 1	MMF	TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
Arm 1	Corticosteroids	TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy

Primary Outcome Measures

Name	Time	Method
Number of Liver Transplant Recipients off of immunosuppression Therapy.	30 months	Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients

Secondary Outcome Measures

Name	Time	Method
The Incidence of adverse events and serious adverse events	30 months	To explore the safety and tolerability of TCD601.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Huddinge, Sweden