Autologous CARTmeso/19 Against Pancreatic Cancer

NCT03497819 | Unknown Early Phase 1 DMC

• 1 other identifier: YXA-meso19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

CART; Pancreatic Cancer; artery infusion

Outcome Measures

Primary Outcomes (1)

• The Percentage of Adverse Events (AEs) ≥ grade 3 assessed through MedDra and CTCAE v4.03 [Time frame: from infusion to 3 month afterward]

  Primary outcome is the percentage of adverse events (AEs) ≥ grade 3. AEs are assessed through MedDra and CTCAE v4.03. Any patients who receive any dose of CART cells will be evaluated

  From first infusion to 3 months afterward

Secondary Outcomes (1)

• Overall Response Rate defined as any improvement measured by imaging following RECIST 1.1 [Time Frame: Day 14 and 1 month after infusion]

  Day 14 and 1 month after infusion, or until patient withdraw consent or receive new therapy

Study Arms (1)

CARTmeso/19 treatment arm

EXPERIMENTAL

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

Biological: CARTmeso CART19

Interventions

CARTmeso CART19 BIOLOGICAL

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

CARTmeso/19 treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Mengtao Zhou, MD

  First Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: April 13, 2018
• Study Start: October 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2020
• Last Updated: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)