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NCT03132792 · ClinicalTrials.gov registry record · Phase 1

AFPᶜ³³²T in Advanced HCC

A Phase 1 study of Hepatocellular Cancer and AFP Expressing Tumors, sponsored by Adaptimmune.

Active
Registry status
Phase 1
Development phase
45
Enrollment target
20
Study locations

NCT03132792 is a Phase 1 study of Hepatocellular Cancer and AFP Expressing Tumors that is active but no longer recruiting, run by Adaptimmune. The registered enrollment target is 45 participants, below the 981-participant average among 15 other Hepatocellular Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT03132792, a Phase 1 study of Hepatocellular Cancer and AFP Expressing Tumors, is active but no longer recruiting, sponsored by Adaptimmune.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
45 participants
Enrollment target
20
Study locations

Study Summary

This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find out what effects, if any, they have in subjects with liver cancer or other AFP expressing tumor types. This study is for subjects who have a blood test positive for appropriate HLA-A\*02 P Group and have adequate AFP protein in blood or tumor, and whose noncancerous liver tissue has very little AFP protein (Liver only). The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion after 3 days of chemotherapy. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose. Subjects will be hospitalized for at least 1 week after receiving their T cells back and then seen frequently by the Study Physician for the next 6 months. After that, subjects will be seen every three months. If subjects have disease progression or withdraw from the study, they will then be entered into a long-term follow up for safety monitoring. In long-term follow up, subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion and annually for the next 10 years.

Interventions

  • GENETIC Autologous genetically modified AFPᶜ³³²T cells

Study Locations (20)

Other

  • Paoli Calmettes Institute - Marseille
  • Centre Eugène Marquis - Rennes
  • Institute Gustave Roussy - Villejuif
  • University Hospital of Barcelona - Barcelona
  • University Hospital of Navarra - Pamplona
  • Beatson West of Scotland Cancer Centre - Glasgow
  • Guy's Hospital - London
  • NIHR UCLH Clinical Research - London

California

  • USC/Norris Comprehensive Cancer Center - Los Angeles
  • UCLA - Los Angeles

Washington

  • Fred Hutchinson Cancer Research Centre - Seattle
  • SCCA Immunotherapy Trials Intake - Seattle

Arizona

  • Mayo Clinic Arizona - Phoenix

Florida

  • University of Miami - Miami

Georgia

  • Winship Cancer Institute - Emory University - Atlanta

Maryland

  • University of Maryland, Greenebaum Cancer Center - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2017-05-08
Est. Completion 2025-12-07
Phase Phase 1

Sponsor

Adaptimmune

13 total trials

What the Registry Record Tells You About NCT03132792

The ClinicalTrials.gov registry entry for NCT03132792 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 981-participant average among 15 other Hepatocellular Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Adaptimmune, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Hepatocellular Cancer appearing as the primary indexed condition, and to 1 intervention - of which Autologous genetically modified AFPᶜ³³²T cells is the first listed.

NCT03132792 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Washington.

Frequently Asked Questions

What is clinical trial NCT03132792 about?

NCT03132792 is a clinical study titled "AFPᶜ³³²T in Advanced HCC". This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The purpose of this ...

What is the current status of trial NCT03132792?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2017-05-08. Estimated completion is 2025-12-07.

What conditions does trial NCT03132792 study?

This clinical trial studies the following conditions: Hepatocellular Cancer, AFP Expressing Tumors.

What interventions are being tested in trial NCT03132792?

The interventions under investigation include: Autologous genetically modified AFPᶜ³³²T cells (GENETIC).

Who is sponsoring clinical trial NCT03132792?

This trial is sponsored by Adaptimmune, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03132792 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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