CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malign… (NCT03682744) | Clinical Trial Compass
WithdrawnPhase 1
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
Stopped: Unable to enroll subjects
United States0Started 2018-09-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years.
✓. Must have documented CEA+ carcinomatosis or malignant ascites as demonstrated by an elevated serum CEA level (≥ 10 ng/mL) or immunohistochemistry on a biopsy or cytologic specimen (archived tissue is acceptable), for determination of CEA expression. Primary tumor may be intact and limited liver and/or lung disease permitted.
✓. Must have at least evaluable disease by physical examination, serum tumor markers, radiologic assessment, tumor markers, or laparoscopic visual assessment.
✓. Have a life-expectancy ≥ 12 weeks and ECOG performance status ≤ 2.
✓. May have low volume of liver metastases defined as \< 50% replacement of the liver volume by metastatic disease, as long as all other eligibility criteria are satisfied.
✓. Be willing and able to comply with the study schedule and all other protocol requirements.
Exclusion criteria
✕. Female patients of childbearing age will be tested for pregnancy. Pregnant patients will be excluded from the study. Males who are actively seeking to have children will be made aware of the unknown risks of this study protocol on human sperm and the need to practice birth control.
✕. Received an investigational study drug within 14 days of leukapheresis or 28 days before receiving first dose of study drug. Exceptions may be granted with medical monitor approval.
✕. Received any approved anticancer medication within 14 days of leukapheresis or 14 days before receiving the first dose of study drug. Exceptions may be granted with medical monitor approval.
What they're measuring
1
Safety of Intraperitoneal CAR-T Cell Infusions as Measured by Number of Participants with Adverse Events
✕. Have any unresolved toxicity \> Grade 2 from previous anticancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve.
✕. Have a history of histologically confirmed metastases outside the peritoneal cavity, lungs, or liver.
✕. Have high volume lung or liver metastases, defined as \>5 lung lesions greater than 1 cm in size or ≥ 50% replacement the liver volume by metastatic disease.
✕. Received CAR-T, CAR-T cell line, CAR-NK, CAR-pNK, or CAR-NK cell line therapies.
✕. Have any of the following laboratory results at Screening (Screening volumes must be independent of blood product treatment):