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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: Recruiting Phase 1 study of Hepatocellular Carcinoma and Hepatocellular Cancer, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety will be reported based on DLTs per dose level as well as reporting specific grades and types of toxicity encountered. Feasibility will be reported descriptively as the fraction of participants overall and per dose level who are able to receive sufficient CAR T cells as required for the specified dose level
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 |
What NCT05003895 shows while recruiting
NCT05003895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05003895's enrollment target sits among peer trials
38 99th of 145 higher than 46 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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