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

ITBMed

Status and phase: Active, not recruiting; Phase 2

Conditions: Liver Transplantation

Treatments: Biological: TCD601; Biological: Cyclophosphamide; Drug: TAC; Drug: Corticosteroids; Drug: MMF

Study type: Interventional

Funder types: Industry

Identifiers

NCT06019507

TCD601G201

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Arm 1

Experimental group

Description:

TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy

Treatment:

Drug: MMF

Drug: Corticosteroids

Drug: TAC

Biological: Cyclophosphamide

Biological: TCD601