NCT04506983

Brief Summary

This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of GPC3-CAR-T cells in patients with hepatocellular carcinoma.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
12

participants targeted

Target at below P25 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

February 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

August 6, 2020

Last Update Submit

January 29, 2022

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Percentage of adverse events

    Percentage of participants with adverse events.

    12months

Secondary Outcomes (2)

  • Objective Remission Rate(ORR)

    12months

  • Proliferation ratio of CAR-T cells

    12months

Study Arms (1)

GPC3-CAR-T cells

EXPERIMENTAL

Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106 /3×106/10×106GPC3-CAR-T cells. Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 21, day 28).

Biological: GPC3-CAR-T cells

Interventions

GPC3-CAR-T cellsBIOLOGICAL

Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106 /3×106/10×106GPC3-CAR-T cells.

GPC3-CAR-T cells

Eligibility Criteria

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

You may qualify if:

  • Age ≧18years, gender unlimited.
  • Failure or intolerance after at least first-line treatment.
  • GPC3 positive(IHC)
  • Patients must have at least one target lesion available for evaluation.
  • BCLC B or C.
  • Child-Pugh grade A or B
  • ECOG is 0 or 1 (one week before enrollment.)
  • Estimated life expectancy ≥ 3 months.
  • Functioning of major organs are normal.
  • Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
  • Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.

You may not qualify if:

  • There are uncontrollable active infections that need systemic treatment.
  • HIV antibody is positive or syphilis antibody is positive.
  • Pregnant or lactating women.
  • hepatic encephalopathy.
  • patients with organ failure:
  • Heart: NYHA heart function grade IV;
  • Liver: Grade C that achieves Child-Turcotte liver function grading;
  • Kidney: kidney failure and uremia;
  • Lung: symptoms of respiratory failure;
  • Brain: a person with a disability.
  • It is undergoing systemic hormones therapy.
  • Impact results show that over 50% of the liver is occupied by tumor .
  • Patients who are still in the observation stage of other antitumor drugs 30 days before blood collection.
  • Patients were received other gene therapy products, or are participating in other clinical trials within 4 weeks prior to cell infusion.
  • Abnormal thyroid function ≧Level 3.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Gong Li, M.A.

    Beijing Tsinghua Changgeng Hospital

    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

August 6, 2020

First Posted

August 10, 2020

Study Start

June 10, 2022

Primary Completion

June 10, 2023

Study Completion

October 10, 2023

Last Updated

February 14, 2022

Record last verified: 2022-01

Locations

CN(1)