Back to resultsGPC3-CAR-T Cells for the Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GPC3-CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Active autoimmune diseases require systemic treatment during the first two years of screening.
- Patients have mental illness or history of drug abuse.
- Patients are participating in other clinical studies.
- The researchers found that it was unsuitable for the recipients to be enrolled.
Sites / Locations
- Beijing Tsinghua Changgung Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GPC3-CAR-T cells
Arm Description
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).
Outcomes
Primary Outcome Measures
Percentage of adverse events
Percentage of participants with adverse events.
Secondary Outcome Measures
Objective Remission Rate(ORR)
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
Proliferation ratio of CAR-T cells
Full Information
NCT ID
NCT04506983
First Posted
August 6, 2020
Last Updated
January 29, 2022
Sponsor
Beijing Tsinghua Chang Gung Hospital
Collaborators
China Immunotech (Beijing) Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04506983
Brief Title
GPC3-CAR-T Cells for the Hepatocellular Carcinoma
Official Title
The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Why Stopped
Adjust the plan
Study Start Date
June 10, 2022 (Anticipated)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tsinghua Chang Gung Hospital
Collaborators
China Immunotech (Beijing) Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
GPC3-CAR-T cells is a novel CAR-T cells which designed for the cell membrane protein Glypican-3. 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, 10×106 GPC3-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 28). The aim of this clinical trial is to evaluate the safety and efficacy of GPC3-CAR-T cells therapy in patients with hepatocellular carcinoma. The primary endpoint is the safety of CAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the CAR-T ratio and CAR gene copied number in PB, PFS, OS and DOR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GPC3-CAR-T cells
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
GPC3-CAR-T cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of adverse events
Description
Percentage of participants with adverse events.
Time Frame
12months
Secondary Outcome Measure Information:
Title
Objective Remission Rate(ORR)
Description
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
Time Frame
12months
Title
Proliferation ratio of CAR-T cells
Time Frame
12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Active autoimmune diseases require systemic treatment during the first two years of screening.
Patients have mental illness or history of drug abuse.
Patients are participating in other clinical studies.
The researchers found that it was unsuitable for the recipients to be enrolled.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gong Li, M.A.
Organizational Affiliation
Beijing Tsinghua Changgeng Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
GPC3-CAR-T Cells for the Hepatocellular Carcinoma
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