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Autologous CARTmeso/19 Against Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03497819
Recruitment Status : Active, not recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Meng-Tao Zhou, First Affiliated Hospital of Wenzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: CARTmeso CART19 Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Autologous Chimeric Antigen Receptor Cells Against Mesothelin and CD19 in Patients With Pancreatic Cancer
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CARTmeso/19 treatment arm
Patients with pancreatic cancer receiving CARTmeso and CART19 autologous cells via artery infusion or i.v. with cyclophosphamide precondition
Biological: CARTmeso CART19
Autologous chimeric antigen receptor T cells with murine scFv, 41BB co-stimulatory domain and CD3ζ signaling domain targeting mesothelin or CD19




Primary Outcome Measures :
  1. The Percentage of Adverse Events (AEs) ≥ grade 3 assessed through MedDra and CTCAE v4.03 [Time frame: from infusion to 3 month afterward] [ Time Frame: From first infusion to 3 months 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 :
  1. Overall Response Rate defined as any improvement measured by imaging following RECIST 1.1 [Time Frame: Day 14 and 1 month after infusion] [ Time Frame: Day 14 and 1 month after infusion, or until patient withdraw consent or receive new therapy ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497819


Locations
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China, Zhejiang
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
Investigators
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Principal Investigator: Mengtao Zhou, MD First Affiliated Hospital of Wenzhou Medical University

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Responsible Party: Meng-Tao Zhou, Director, First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03497819     History of Changes
Other Study ID Numbers: YXA-meso19
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meng-Tao Zhou, First Affiliated Hospital of Wenzhou Medical University:
CART
Pancreatic Cancer
artery infusion
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases