RecruitingPhase 1NCT05003895

GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies

Phase I Study of GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies


Sponsor

National Cancer Institute (NCI)

Enrollment

38 participants

Start Date

Dec 8, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specialized immune cell therapy called GPC3-targeted CAR-T cell therapy in people with advanced liver cancer (hepatocellular carcinoma) or other solid tumors that express a protein called GPC3. CAR-T therapy involves engineering a patient's own immune cells to recognize and attack cancer cells. **You may be eligible if...** - You have been diagnosed with liver cancer (HCC) or another solid tumor confirmed by biopsy - Your tumor expresses the GPC3 protein (≥25% of tumor cells, confirmed by a fresh biopsy) - Your cancer has progressed on or you could not tolerate at least one prior treatment - You have at least one measurable tumor lesion - You are willing to undergo a tumor biopsy before starting treatment **You may NOT be eligible if...** - Your tumor does not express GPC3 - You are not willing to undergo the required biopsy - Your general health or organ function is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Daily x 3 doses on Day -3, -2, -1 300 mg/m2 IV infusion (200 mg/m\^2 in Dose Level -1)

BIOLOGICALCAR-T cell

Single infusion on Day 0

DRUGFludarabine

Daily x 2 doses on Day -2 and -1 30 mg/m\^2 IV infusion administered following cyclophosphamide


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05003895


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