This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.
Patients undergo leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for CEA. Cells are expanded in culture and returned to the patient by intraperitoneal infusion at specific cell doses. One anti-CEA CAR-T dose per patient is planned. Additional cycles may be administered at the discretion of the principal investigator. Normal peritoneal and tumor biopsies will be obtained at the time of the CAR-T infusion, on the final day of the treatment period, and during reporting interval #3.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Intraperitoneal delivery of anti-CEA CAR-T cells
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
Safety of Intraperitoneal CAR-T Cell Infusions as Measured by Number of Participants with Adverse Events
To determine the safety and maximum tolerated dose (MTD) following intraperitoneal infusion(s) of anti-CEA CAR-T cells for inoperable CEA+ peritoneal metastases or malignant ascites.
Time frame: 16 weeks
Progression-Free Survival
As a measure of activity, Progression-free survival (PFS) will be assessed. The events for the assessment of PFS are disease progression and death events
Time frame: 20 weeks
Overall Survival
As a measure of activity, Overall Survival (OS) will be assessed. The events for the assessment of OS are death events.
Time frame: 20 weeks
Bowel Obstruction Free Survival
Measuring the time frame in which a patient does not experience a bowel obstruction
Time frame: 20 weeks
Changes in Quality of Life
Changes in quality of life measured by Quality of Life Index (IQI) survey pre and post-treatment
Time frame: 20 weeks
Response by the Peritoneal Carcinomatosis Index (PCI)
Direct visualization of tumor burden assessment by the PCI pre and post-treatment
Time frame: 16 weeks
Radiographic treatment response by MRI
Changes in tumor size
Time frame: 20 weeks
Radiographic treatment response by PET
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes in tumor metabolic activity
Time frame: 20 weeks
Serologic response rates
Measurement of CEA and CA19-9
Time frame: 20 weeks