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

Sponsor
ITB-Med LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06019507
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
83.1
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jun 29, 2022
Anticipated Primary Completion Date :
Jun 1, 2026
Anticipated Study Completion Date :
Jun 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy

Biological: TCD601
Investigational Product
Other Names:
  • siplizumab

    • Biological: Cyclophosphamide
    Conditioning Regimen

    Drug: TAC
    Immunosuppression Therapy
    Other Names:
  • Tacrolimus

    • Drug: MMF
    Immunosuppression Therapy
    Other Names:
  • Mycophenolate Mofetil

    • Drug: Corticosteroids
    Immunosuppression Therapy

    Outcome Measures

    Primary Outcome Measures

    1. Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients [30 months]

      The number of transplant recipients patients off of immunosuppression therapy

    Secondary Outcome Measures

    1. To explore the safety of TCD601 [30 months]

      The number of adverse events and serious adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinska University Hospital Stockholm Huddinge Sweden

    Sponsors and Collaborators

    • ITB-Med LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ITB-Med LLC
    ClinicalTrials.gov Identifier:
    NCT06019507
    Other Study ID Numbers:
    • TCD601G201
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycophenolic Acid
    Cyclophosphamide
    Tacrolimus

    Study Results

    No Results Posted as of Aug 31, 2023