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Study of Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases

NCT04037241 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2022-04-01

No results posted yet for this study

Summary

This study is a randomized open-label phase 2b study of the efficacy and safety of regional infusion therapy with Anti-CEA CAR-T cells using the hepatic immunotherapy for metastases (HITM) method and the Trisalus pressure enabling drug delivery (PEDD) device alternating with systemic chemotherapy versus chemotherapy alone in patients with CEA-expressing pancreatic adenocarcinoma with liver metastases.

Conditions

  • Malignant Tumor of Pancreas Metastatic to Liver

Interventions

BIOLOGICAL

Anti-CEA CAR-T cells

Doses will be delivered by hepatic arterial infusions using a pressure enabled drug delivery (PEDD) device

DRUG

gemcitabine/nab paclitaxel

systemic chemotherapy regimen

DRUG

NLIR+FU/FA

systemic chemotherapy regimen

DRUG

Capecitabine

systemic chemotherapy regimen

Sponsors & Collaborators

  • Sorrento Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ying Yan, MD MS · Sorrento Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-01-01
Completion
2022-01-01
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04037241 on ClinicalTrials.gov