Autologous CARTmeso/19 Against Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Pilot Study of Autologous Chimeric Antigen Receptor Cells Against Mesothelin and CD19 in Patients With Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03497819
• Other study ID #: YXA-meso19
• Status: Active, not recruiting
• Phase: Early Phase 1
• First received: October 27, 2017
• Last updated: April 12, 2018
• Start date: October 1, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: April 2018
• Source: First Affiliated Hospital of Wenzhou Medical Univeristy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• CARTmeso CART19
Autologous chimeric antigen receptor T cells with murine scFv, 41BB co-stimulatory domain and CD3? signaling domain targeting mesothelin or CD19

Locations

Country	Name	City	State
China	First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical Univeristy

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Response Rate defined as any improvement measured by imaging following RECIST 1.1 [Time Frame: Day 14 and 1 month after infusion]	Secondary outcome is overall response rate. A response is defined as any improvement measured by imaging following RECIST 1.1. Only patients who receive infusions per protocol will be evaluated.	Day 14 and 1 month after infusion, or until patient withdraw consent or receive new therapy