Back to resultsAutologous CARTmeso/19 Against Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CARTmeso CART19
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring CART, Pancreatic Cancer, artery infusion
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
Sites / Locations
- First Affiliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CARTmeso/19 treatment arm
Arm Description
Patients with pancreatic cancer receiving CARTmeso and CART19 autologous cells via artery infusion or i.v. with cyclophosphamide precondition
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03497819
First Posted
October 27, 2017
Last Updated
April 12, 2018
Sponsor
First Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03497819
Brief Title
Autologous CARTmeso/19 Against Pancreatic Cancer
Official Title
Pilot Study of Autologous Chimeric Antigen Receptor Cells Against Mesothelin and CD19 in Patients With Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
CART, Pancreatic Cancer, artery infusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CARTmeso/19 treatment arm
Arm Type
Experimental
Arm Description
Patients with pancreatic cancer receiving CARTmeso and CART19 autologous cells via artery infusion or i.v. with cyclophosphamide precondition
Intervention Type
Biological
Intervention Name(s)
CARTmeso CART19
Intervention Description
Autologous chimeric antigen receptor T cells with murine scFv, 41BB co-stimulatory domain and CD3ζ signaling domain targeting mesothelin or CD19
Primary Outcome Measure Information:
Title
The Percentage of Adverse Events (AEs) ≥ grade 3 assessed through MedDra and CTCAE v4.03 [Time frame: from infusion to 3 month afterward]
Description
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
Time Frame
From first infusion to 3 months afterward
Secondary Outcome Measure Information:
Title
Overall Response Rate defined as any improvement measured by imaging following RECIST 1.1 [Time Frame: Day 14 and 1 month after infusion]
Description
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.
Time Frame
Day 14 and 1 month after infusion, or until patient withdraw consent or receive new therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mengtao Zhou, MD
Organizational Affiliation
First Affiliated Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Autologous CARTmeso/19 Against Pancreatic Cancer
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