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NCT06019507 Clinical Trial

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

Liver Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06019507
Other study ID # TCD601G201
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 29, 2022
Est. completion date June 2029

Study information
Verified date December 2023
Source ITB-Med LLC
Contact Jesse Scott, MPH
Phone 212-969-7821
Email jesse.scott@itb-med.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date June 2029
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• TCD601
Investigational Product
• Cyclophosphamide
Conditioning Regimen
Drug:
• TAC
Immunosuppression Therapy
• MMF
Immunosuppression Therapy
• Corticosteroids
Immunosuppression Therapy

Locations
Country Name City State
Sweden Karolinska University Hospital Stockholm Huddinge

Sponsors (1)
Lead Sponsor Collaborator
ITB-Med LLC

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Liver Transplant Recipients off of immunosuppression Therapy. Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients 30 months
Secondary The Incidence of adverse events and serious adverse events To explore the safety and tolerability of TCD601. 30 months
See also
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Withdrawn NCT00585429 - Evaluation of Kidney Disease in Liver Transplant Recipients N/A
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Terminated NCT00585858 - Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant N/A
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Withdrawn NCT00167492 - Enteric Coated Myfortic for Liver Transplant Recipients Phase 4
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