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NCT05003895 · ClinicalTrials.gov registry record · Phase 1
GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies
A Phase 1 study of Hepatocellular Carcinoma and Hepatocellular Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT05003895 is a Phase 1 study of Hepatocellular Carcinoma and Hepatocellular Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05003895, a Phase 1 study of Hepatocellular Carcinoma and Hepatocellular Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: A new cancer treatment takes a person s own T cells, modifies them in a laboratory so they can better fight cancer cells, and then gives them back to the person. Researchers want to see if this treatment can help people with a certain types of cancer. Objective: To see if a personalized immune treatment, anti-GPC3 CAR-T cells, is safe. Eligibility: Adults aged 18 years and older who have Glypican-3 (GPC3) positive solid tumor malignancy. Design: Participants will be screened with the following: Blood and urine tests Medical history Physical exam Heart function tests Review of their symptoms and their ability to perform their normal activities Tumor biopsy Imaging scan of the chest, abdomen, and pelvis Participants will have leukapheresis. They may have an IV (intravenous catheter, a small tube put into an arm vein) inserted into each arm or get a central line. Blood will be removed. A machine will separate the white blood cells from their blood. The rest of their blood will be returned to them. Participants will be admitted to the hospital for about 2 weeks. They will get the chemotherapy drugs fludarabine and cyclophosphamide by IV for 3 days. Then they will receive the modified white blood cells by IV. Participants will have frequent blood draws. They will give blood and tumor samples for research. Participants will have follow-up visits for the next 15 years. Then they will be contacted by email or phone for the rest of their life. If their disease does not get worse after 5 years, they will continue to be invited to do imaging studies every 6 months.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL CAR-T cell
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05003895
The ClinicalTrials.gov registry entry for NCT05003895 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (85% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT05003895 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05003895 about?
NCT05003895 is a clinical study titled "GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies". Background: A new cancer treatment takes a person s own T cells, modifies them in a laboratory so they can better fight cancer cells, and then gives them back to the person. Researchers want to see if this treatment can help people with a certain types of cancer. Objective: To see if a personaliz...
What is the current status of trial NCT05003895?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2021-12-08. Estimated completion is 2027-12-31.
What conditions does trial NCT05003895 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Hepatocellular Cancer, Metastatic Hepatocellular Carcinoma.
What interventions are being tested in trial NCT05003895?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), CAR-T cell (BIOLOGICAL).
Who is sponsoring clinical trial NCT05003895?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05003895 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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