NCT06019507

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
37mo left

Started Jun 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jun 2022Jun 2029

Study Start

First participant enrolled

June 29, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

3.9 years

First QC Date

August 25, 2023

Last Update Submit

November 25, 2024

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Incidence of adverse events and serious adverse events

    30 months

Study Arms (1)

Arm 1

EXPERIMENTAL

TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy

Biological: TCD601Biological: CyclophosphamideDrug: TACDrug: MMFDrug: Corticosteroids

Interventions

TCD601BIOLOGICAL

Investigational Product

Also known as: siplizumab
Arm 1
CyclophosphamideBIOLOGICAL

Conditioning Regimen

Arm 1
TACDRUG

Immunosuppression Therapy

Also known as: Tacrolimus
Arm 1
MMFDRUG

Immunosuppression Therapy

Also known as: Mycophenolate Mofetil
Arm 1
CorticosteroidsDRUG

Immunosuppression Therapy

Arm 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or nursing (lactating) women
  • Subjects with a history of TB or latent TB infection
  • Subjects with a history of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Huddinge, Sweden

Location

MeSH Terms

Interventions

siplizumabCyclophosphamideTacrolimusMycophenolic AcidAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsMacrolidesLactonesCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Kellie Kennon, BSN

    ITB-MED

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 31, 2023

Study Start

June 29, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2029

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

SE(1)