Clinical trialPhase 1Terminated
Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases
Phase 1b Study of the Efficacy and Safety of CAR2 Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases Resistant to Standard Therapy Using the HITM Method and Pressure Enabled Delivery Device
- Outcome
- Stopped earlyLimited enrollment. (Enrollment)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 29 July 2019
- Expected end
- 21 May 2021
- Enrollment
- 2 participants
- Sites
- 1
- Primary outcomes
- Assess preliminary efficacy by overall survival
- Sponsor
- Industry
- Results posted
- No
- Last update
- 17 January 2023
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Brief summary public domain (ClinicalTrials.gov)
This study is an open-label, single arm phase 1b safety study of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions for pancreatic carcinoma patients with carcinoembryonic antigen positive (CEA+) liver metastases resistant to standard therapy who meet all other eligibility criteria.
Detailed description public domain (ClinicalTrials.gov)
Patients will receive weekly 3 doses of CAR2 Anti-CEA CAR-T cells in each 28-day cycle by hepatic arterial infusions using a Pressure Enhanced Delivery Device (PEDD) with low dose systemic IL-2 support. Patients may receive up to 3 cycles of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions, per discretion of the investigator. All patients who receive investigational CAR-T therapy will be included in the analyses and summaries of safety, efficacy, pharmacokinetic, and pharmacodynamic assessments.