Summary

Eligibility
for people ages 18-76 (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Julia Carnevale (ucsf)
Headshot of Julia Carnevale
Julia Carnevale

Description

Summary

A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers

Official Title

Open-label, Multicenter, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Subjects With Advanced Gastric, Pancreatic, or Other Specified Digestive System Cancers

Details

This is an open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric, pancreatic or other specified digestive system cancers.

Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT041). Following manufacture of the drug product, subjects will receive preconditioning prior to CT041 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Keywords

Gastric Cancer, Pancreatic Cancer, CAR-T, Pancreatic Neoplasms, anti-claudin18.2 chimeric antigen receptor T-cell therapy

Eligibility

Locations

  • UCSD
    San Diego California 92093 United States
  • UCSF
    San Francisco California 94143 United States
  • University of Southern California
    Los Angeles California 90089 United States
  • City of Hope
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Julia Carnevale (ucsf)
    Dr. Carnevale is a physician-scientist who treats patients with gastrointestinal cancers, and also performs research into finding novel therapies for these diseases.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CARsgen Therapeutics Co., Ltd.
ID
NCT04404595
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 110 study participants
Last Updated