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New treatment option for Hepatocellular Carcinoma
Official title GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT05003895
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Histopathological confirmation of HCC or other solid tumor malignancy by the NCI Laboratory of Pathology
- Participants must:
- have progressed on at least 1 prior line of treatment OR --been intolerant of at least 1 prior line of treatment.
- Participants must have at least 1 focus of disease that is amenable to mandatory tumor biopsy prior to study treatment initiation to determine tumor...
- Tumor must have GPC3 positivity of \>= 25% by immunohistochemistry on freshly collected biopsy
You likely can't join if
- Prior systemic therapy, an investigational therapy, radiation, and/or surgery within 2 weeks prior to treatment initiation.
- 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...
- Child-Pugh class B or C liver function
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Any form of primary immunodeficiency (e.g. severe combined immunodeficiency).
- HIV-positive participants are excluded because HIV causes complicated immune deficiency and study treatment can pose more risks for these...
See the full eligibility criteria
- Histopathological confirmation of HCC or other solid tumor malignancy by the NCI Laboratory of Pathology
- Participants must:
- have progressed on at least 1 prior line of treatment OR --been intolerant of at least 1 prior line of treatment.
- Participants must have at least 1 focus of disease that is amenable to mandatory tumor biopsy prior to study treatment initiation to determine tumor GPC3 expression and be willing to undergo this. Ideally, the biopsied...
- Tumor must have GPC3 positivity of \>= 25% by immunohistochemistry on freshly collected biopsy
- Participants must have at least 1 measurable lesion by RECIST version 1.1
- Participants must have a disease that is not amenable to potentially curative resection, ablation, or transplantation.
- Age \>= 18 years.
- Performance status (ECOG) 0-1
- Participants must have adequate organ and marrow function as defined below: ANC: \>= 1,000/mcL Platelets: \>= 75,000/mcL Hemoglobin: \>= 8 g/dL total bilirubin: If cirrhosis present: Part of Child Pugh requirement If no...
- 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.
- Room air oxygen saturation of 92% or greater.
- Treatment-related toxicities must be resolved to \<= grade 1.
- For participants with brain metastases: Participants with \<=3 (three or fewer) brain metastases that have been treated with surgery or stereotactic radiosurgery or other form of treatment are eligible. Lesions that...
- The study drugs are harmful to developing human fetus. For this reason, women of childbearing potential must agree to use highly effective contraception (hormonal, intrauterine device (IUD), abstinence, surgical...
- HBV infected participants must be on antivirals and have HBV DNA \< 100IU/mL. HCV infected participants can be enrolled with close HCV RNA level monitoring.
- Participants must be able to understand and be willing to sign a written informed consent.
- For participants that do not have a legally authorized representative in place, one must be identified before study treatment starts
- Prior systemic therapy, an investigational therapy, radiation, and/or surgery within 2 weeks prior to treatment initiation.
- 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...
- Child-Pugh class B or C liver function
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Any form of primary immunodeficiency (e.g. severe combined immunodeficiency).
- HIV-positive participants are excluded because HIV causes complicated immune deficiency and study treatment can pose more risks for these participants.
- Participants receiving systemic steroids \>= 0.5 mg prednisone equivalent/kg/day. Steroid creams, ointments, and eye drops are allowed. Dose adjustment or discontinuation of medication must occur at least 24 hours prior...
- History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.
- Hospitalization within 7 days prior to treatment initiation.
- Pregnant women are excluded from this study because study therapy can cause fetal harm. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with study therapy...
- Participants who received live or attenuated vaccine or virus-based vaccine within 30 days before initiation of study therapy
- Participants with a history of seizure disorder
- Participants with an expected life expectancy of less than 3 months before initiation of study therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.