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Active, Not Recruiting

NCT Number: NCT06019507

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Liver Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska University Hospital

Stockholm, Huddinge, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCD601

Biological

Investigational Product

Other names: siplizumab

Cyclophosphamide

Biological

Conditioning Regimen

TAC

Drug

Immunosuppression Therapy

Other names: Tacrolimus

MMF

Drug

Immunosuppression Therapy

Other names: Mycophenolate Mofetil

Corticosteroids

Drug

Immunosuppression Therapy

Primary outcomes

  1. Number of Liver Transplant Recipients off of immunosuppression Therapy.

    Time frame: 30 months

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

Secondary outcomes

  1. The Incidence of adverse events and serious adverse events

    Time frame: 30 months

    To explore the safety and tolerability of TCD601.

Sponsors and collaborators

Lead sponsor

ITB-Med LLC

Industry

Registry information

Official study title

A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
Aug 31, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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