Clinical trialPhase 1Withdrawn
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
Immunotherapy for Peritoneal Carcinomatosis (IPC) - A Phase I Study of the Safety and Efficacy of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment of CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites
- Outcome
- Stopped earlyUnable to enroll subjects (Enrollment)
- Phase
- Phase 1
- Status
- Withdrawn
- Study type
- Interventional
- Start
- 13 September 2018
- Expected end
- March 2021
- Enrollment
- 0 participants
- Sites
- 2
- Primary outcomes
- Safety of Intraperitoneal CAR-T Cell Infusions as Measured by Number of Participants with Adverse Events
- Sponsor
- Industry
- Results posted
- No
- Last update
- 6 April 2022
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Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.