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

Phase 2Active Not RecruitingNCT06019507

ITB-Med LLC12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Liver Transplantation

Interventions

TCD601BIOLOGICAL

Investigational Product

CyclophosphamideBIOLOGICAL

Conditioning Regimen

TACDRUG

Immunosuppression Therapy

MMF

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska University Hospital

Stockholm, Huddinge, Sweden

Outcomes

Primary Outcomes

Number of Liver Transplant Recipients off of immunosuppression Therapy.

Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients

Time frame: 30 months

Secondary Outcomes

The Incidence of adverse events and serious adverse events

To explore the safety and tolerability of TCD601.

Time frame: 30 months

Data from ClinicalTrials.gov

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