OncoMatch/Clinical Trials/NCT05003895
GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies
Is NCT05003895 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CAR-T cell and Cyclophosphamide for hepatocellular carcinoma.
Treatment: Cyclophosphamide · CAR-T cell · Fludarabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: GPC3 positive (≥ 25% by immunohistochemistry)
Tumor must have GPC3 positivity of >= 25% by immunohistochemistry on freshly collected biopsy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any prior systemic therapy
have progressed on at least 1 prior line of treatment OR been intolerant of at least 1 prior line of treatment
Cannot have received: systemic therapy, investigational therapy, radiation, and/or surgery
Prior systemic therapy, an investigational therapy, radiation, and/or surgery within 2 weeks prior to treatment initiation.
Cannot have received: anti-PD-1 or anti-PD-L1 antibodies or other agents that can stimulate immune activity
Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation.
Lab requirements
Blood counts
ANC: >= 1,000/mcL; Platelets: >= 75,000/mcL; Hemoglobin: >= 8 g/dL
Kidney function
Creatinine < 1.5x institution upper limit of normal OR >= 50 mL/min/1.73 m^2 for participant with creatinine levels >= 1.5 X institutional ULN; Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard
Liver function
total bilirubin: If cirrhosis present: Part of Child Pugh requirement; If no cirrhosis: bilirubin should be <= 1.5 x ULN; ALT or AST: <= 5 x ULN; Child-Pugh class B or C liver function excluded
Cardiac function
Normal cardiac ejection fraction (>= 50% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 4 weeks before treatment initiation
Participants must have adequate organ and marrow function as defined below: ... Child-Pugh class B or C liver function [excluded]. Normal cardiac ejection fraction (>= 50% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 4 weeks before treatment initiation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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