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CAR T-cell Therapy

CAR-T Cell Therapy for Liver Cancer

Phase 1
Recruiting
Led By Tim F Greten, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HBV infected subjects must be on antivirals and have HBV DNA < 100IU/mL
Treatment-related toxicities must be resolved to <= grade 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study Summary

This trial is testing a personalized cancer treatment, CAR-T cells, to see if it is safe for people with a certain type of liver cancer.

Who is the study for?
Adults over 18 with advanced liver cancer expressing GPC3, who have tried or can't tolerate standard chemotherapy. They must be able to undergo a tumor biopsy, have measurable disease not suitable for surgery or transplantation, and proper organ function. Pregnant women and those with severe illnesses or certain medical conditions are excluded.Check my eligibility
What is being tested?
The trial is testing CAR-T cell therapy where patients' T cells are modified to fight liver cancer better. Participants will receive chemo drugs fludarabine and cyclophosphamide before getting their modified T cells back via IV. The study includes long-term follow-up.See study design
What are the potential side effects?
Potential side effects include reactions from the infusion of modified T cells, effects from chemotherapy like nausea and low blood counts, increased risk of infection, fatigue, and possibly autoimmune-like symptoms due to immune system activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have hepatitis B, am on antivirals, and my HBV DNA level is below 100IU/mL.
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My side effects from previous treatments are mild.
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I am 18 years old or older.
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I can have a biopsy to check my tumor for GPC3.
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My tumor shows high GPC3 levels in recent tests.
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I am fully active or can carry out light work.
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My liver cancer worsened after the first treatment or I couldn't tolerate the standard chemotherapy.
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My condition cannot be cured with surgery or other similar treatments.
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My heart pumps well and I don't have serious fluid around it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
T-Lymphocyte
Secondary outcome measures
To characterize overall survival (OS)
To determine the best overall response (BOR) rate according to Response Evaluation Criteria (by RECIST v 1.1) of treatment with T-cells, expressing a novel humanized anti-GPC3 chimeric antigen receptor in participants with advanced HCC, expressi...

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/ Arm 2Experimental Treatment3 Interventions
MTD of CAR-T cells
Group II: 1/ Arm 1Experimental Treatment3 Interventions
Escalating doses of CAR-T cells
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,309 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
1,427 Total Patients Enrolled
5 Trials studying Liver Cancer
626 Patients Enrolled for Liver Cancer

Media Library

CAR-T cell (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05003895 — Phase 1
Liver Cancer Research Study Groups: 1/ Arm 1, 2/ Arm 2
Liver Cancer Clinical Trial 2023: CAR-T cell Highlights & Side Effects. Trial Name: NCT05003895 — Phase 1
CAR-T cell (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05003895 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How perilous is the application of CAR-T cell therapy for individuals?

"Due to the limited data available, CAR-T cells were given a score of 1 on our safety scale. As this is only a Phase 1 trial, there has been minimal clinical evidence that supports its efficacy and security."

Answered by AI

What maladies is CAR-T cell therapy commonly employed to alleviate?

"CAR-T cell therapy is a potent treatment option for multiple sclerosis, in addition to certain lymphomas, leukemias, myelocytic conditions, acute diseases and retinoblastoma."

Answered by AI

Have prior experiments featured CAR-T cells?

"At this moment, 889 medical studies are being conducted on CAR-T cell therapy. Of those trials, 161 of them have reached Phase 3 and are located in Philadelphia, Pennsylvania with a total of 28443 operational trial sites available world wide."

Answered by AI

Are opportunities for participation in this experiment still available to individuals?

"Yes, according to the clinicaltrials.gov website, this clinical trial is actively searching for participants. This research was initially posted on December 8th 2021 and last updated October 4th 2022. The study requires 38 patients from a single medical centre."

Answered by AI

How many applicants are being considered for entry into this research project?

"Affirmative. Clinicaltrials.gov displays that this clinical study, which was initially published on December 8th 2021, is actively searching for participants to enroll in the trial. A total of 38 individuals are required from 1 medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Alaska
How old are they?
< 18
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. National Institutes of Health Clinical Center: < 24 hours
Average response time
  • < 1 Day
~9 spots leftby Dec 2024