Estado del programa
ReclutamientoFase
Fase 1Inmunoterapia previa permitida
SíEnsayo dirigido por el CRC
SíDrogas
GCC19CARTEtiquetas
MSI-H/ MMRd, MSS/ MMRpComentarios
CAR-T cells therapy (GCC19CART) for CRC metastatic patients, with liver disease only who are not candidates for surgical resection.
Patients should have received standard of care chemotherapy. Must have less than 5 liver lesions, with largest lesion less than 3 cm.
| Ubicación | Situación |
|---|---|
| Estados Unidos | |
|
City of Hope Comprehensive Cancer Center Duarte, California 91010 |
Reclutamiento |
|
University of California San Francisco Medical Center San Francisco, California 94143 |
Reclutamiento |
|
University of Colorado Hospital - Anschutz Cancer Pavilion Aurora, Colorado 80045 |
Reclutamiento |
|
Instituto Oncológico Dana-Farber Boston, Massachusetts 02215-5418 |
Reclutamiento |
|
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan 48109 |
Aún no se ha contratado |
|
Baylor Scott & White Research Institute Dallas, Texas 75204 |
Reclutamiento |
Criterios de inclusión
Criterios de inclusión:
Adults > 18 years old
Clinical and histopathological diagnosis of metastatic colorectal cancer
Guanylate Cyclase (GCC) positive disease as determined by immunohistochemistry (IHC). Positivity on staining of archival tumor tissue is adequate.
Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)
No surgical options with curative intent.
Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment must have been discontinued for disease progression or intolerance to therapy.
Have at least one extracranial measurable target lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard.
Criterios de exclusión
Criterios de exclusión:
Subjects with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive track, urinary bladder, or blood vessel) with GCC19CART therapy.
No active infectious diseases or comorbid conditions that would interfere with safety or data quality.
Subjects with active infection requiring systemic therapy or causing fever (temperature > 38.1˚C) or subjects with unexplained fever (temperature > 38.1˚C) within 7 days prior to enrollment (leukapheresis) and reconfirmed prior to the day of investigational product administration.
Pregnant or breast-feeding women
Other protocol defined Inclusion/Exclusion criteria may apply
