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

November 25, 2024 updated by: ITB-Med LLC

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Huddinge
      • Stockholm, Huddinge, Sweden
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
Biological: TCD601
Investigational Product
Other Names:
  • siplizumab
Drug: Corticosteroids
Immunosuppression Therapy
Biological: Cyclophosphamide
Conditioning Regimen
Drug: TAC
Immunosuppression Therapy
Other Names:
  • Tacrolimus
Drug: MMF
Immunosuppression Therapy
Other Names:
  • Mycophenolate Mofetil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence of adverse events and serious adverse events
Time Frame: 30 months
To explore the safety and tolerability of TCD601.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ITB-Med LLC

Investigators

  • Study Director: Kellie Kennon, BSN, ITB-MED

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCD601G201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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