Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT07224568
Eligibility Criteria:
1. Procurement Eligibility
Inclusion Criteria:
* Diagnosis of a solid tumor expressing GPC3
* Karnofsky score of \>=60%
* Life expectancy of \>16 weeks
* Informed consent explained to, understood by and signed by participant or participant's legally authorized representative
For patients with hepatocellular carcinoma only:
* Barcelona Liver Cancer Stage A, B or C
* Child-Pugh-Turcotte Score \<7
Exclusion Criteria:
* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.
* History of organ transplantation
* Known HIV positivity
* Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
2. Treatment eligibility
Inclusion Criteria:
* Karnofsky score of \>=60%
* Life expectancy of \>16 weeks
* Informed consent explained to, understood by and signed by patient/guardian.
* Adequate organ function
* Adequate laboratory values
* Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle
* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
* Informed consent explained to, understood by and signed by patient/guardian.
For patients with hepatocellular carcinoma only:
* Barcelona Liver Cancer Stage A, B or C
* Child-Pugh Turcotte Score \<7
Exclusion Criteria:
* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.
* History of organ transplantation
* Known HIV positivity
* Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
* Pregnancy or lactation
* Systemic steroid treatment (≥ 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07224568
Study Brief:
Protocol Section:
NCT07224568