GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)
About this trial
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 criteria
Qualifiers
Histopathological confirmation of HCC or other solid tumor malignancy by the NCI Laboratory of Pathology
have progressed on 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 lesion should not be one of the target measurable lesions, although this can be up to the discretion of the investigators.
Tumor must have GPC3 positivity of >= 25% by immunohistochemistry on freshly collected biopsy
Disqualifiers
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 initiation.
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 that would limit compliance with study requirements.
Trial design
Treatments tested in this trial
- Cyclophosphamide
- CAR-T cell
- Fludarabine
Treatment groups
38 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov