Autologous CARTmeso/19 Against Pancreatic Cancer

NCT ID: NCT03497819

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-10-31

Brief Summary

Pancreatic cancer patients receive chimeric antigen receptor (CAR) T cells against mesothelin (CARTmeso) or CD19 (CART19) cells administered at 3 days via pancreatic artery infusion or i.v. after preconditioning of cyclophosphamide. Both CART cells are autologous. CARTmeso cells target pancreatic cells which highly express mesothelin, while CART19 cells target tumor-associated B cells expressing cluster of differentiation antigen 19 (CD19) which are mostly immunosuppressive. The investigators hypothesize that this combination therapy may enhance the efficacy of CARTmeso cells in the body. Additionally, a medium dose of cyclophosphamide is used to enhance the engraftment of CART cells.

Detailed Description

This is a single arm, open-label, pilot study to determine the safety and feasibility of combination CARTmeso cells and CART19 cells in patients with pancreatic cancer following lymphodepletion with cyclophosphamide. Both cells contain CAR proteins consisting of a murine-derived single chain antibody fragment (scFv), cluster of differentiation antigen 137 (41BB) co-stimulatory domain and cluster of differentiation antigen 3 zeta chain (CD3ζ) signaling domain transduced by lentivirus

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CARTmeso/19 treatment arm

Patients with pancreatic cancer receiving CARTmeso and CART19 autologous cells via artery infusion or i.v. with cyclophosphamide precondition

Group Type: EXPERIMENTAL

CARTmeso CART19

Intervention Type: BIOLOGICAL

Autologous chimeric antigen receptor T cells with murine scFv, 41BB co-stimulatory domain and CD3ζ signaling domain targeting mesothelin or CD19

Interventions

CARTmeso CART19

Autologous chimeric antigen receptor T cells with murine scFv, 41BB co-stimulatory domain and CD3ζ signaling domain targeting mesothelin or CD19

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• serum soluble mesothelin-related protein (SMRP) > 0.4 nanomolar/L
• Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease

• 18 years of age and ≤65
• Life expectancy greater than 3 months
• Satisfactory organ and bone marrow function

Exclusion Criteria

• Participation in a therapeutic investigational study within 4 weeks prior to the screening visit
• Active invasive cancer other than pancreatic cancer
• HIV, hepatitis B/C virus, or infections
• Active autoimmune disease requiring immunosuppressive therapy within 4 weeks
• Planned concurrent treatment with systemic high dose corticosteroids
• Patients requiring supplemental oxygen therapy
• Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Meng-Tao Zhou

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mengtao Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wenzhou Medical University

Locations

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

YXA-meso19

Identifier Type: -

Identifier Source: org_study_id