NCT02166177

Brief Summary

'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

June 16, 2014

Last Update Submit

January 9, 2019

Conditions

End-stage Liver Disease

Outcome Measures

Primary Outcomes (2)

  • Rate of dose limiting toxicities (DLTs)

    rate of adverse events qualifying as dose limiting toxicities

    1 month after IMP administration

  • Graft Loss

    Rate of cellular rejection

    24 months

Secondary Outcomes (5)

  • Immunosuppressive doses

    24 months

  • Prevention of acute and chronic rejection

    24 months

  • Acute and Chronic Toxicity

    24 months

  • Liver histology

    12 months

  • Rate of successful immunosuppressive drug withdrawal

    24 months

Other Outcomes (1)

  • Immunological biomarkers

    12 months

Study Arms (1)

Autologous Regulatory T cell therapy

EXPERIMENTAL

Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose)

Drug: Autologous regulatory T cell product

Interventions

Autologous regulatory T cell productDRUG

Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose). The patients also receive rabbit Antithymocyte Globulin (rATG), tacrolimus, and sirolimus.

Autologous Regulatory T cell therapy

Eligibility Criteria

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

You may qualify if:

  • Able to give informed consent
  • adult patients with end-stage liver disease listed for primary liver transplant;
  • calculated MELD score ≤ 25 at time of transplantation

You may not qualify if:

  • HIV or RNA-positive Hepatitis C Virus infection;
  • autoimmune liver disease
  • previous organ transplant
  • Ebstein Virus and/or Cytomegalovirus sero-negativity
  • chronic use of systemic immunosuppressants
  • hepatocellular carcinoma outside Milano criteria
  • leukocytes \<1.5x10\^9/L and/or platelets \<50x10\^9/L.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kings College Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Giovanna Lombardi, PhD

    King's College London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 18, 2014

Study Start

June 1, 2014

Primary Completion

January 22, 2018

Study Completion

January 22, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

GB(1)