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Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03638193
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
The First Affiliated Hospital with Nanjing Medical University
Information provided by (Responsible Party):
Shenzhen BinDeBio Ltd.

Brief Summary:
This is a study in which pancreatic cancer patients receive a immunotherapy with CART-meso cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells lentivirally transduced to express anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains.The lymphodepletion with cyclophosphamide may prolong the persistence of CART cells.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: CART-meso cells Not Applicable

Detailed Description:

This study is being conducted to assess the safety and efficacy of immunotherapy with CART-meso cells in dose escalation design. The trial will begin in Cohort 1 and progress to Cohorts 2, depending upon dose limiting toxicity (DLT) assessment .

Subjects will be enrolled serially, but infusions will be staggered to allow assessment of DLTs for determination of cohort progression, expansion, or dose de-escalation.

Cohort 1 subjects will receive a single dose of 1-3x10^7 /m^2 lentiviral transduced CART-meso cells after conditioning chemotherapeutic regimen.

Cohort 2 subjects will receive a single dose of 1-3x10^8 /m^2 lentiviral transduced CART-meso cells cells after conditioning chemotherapeutic regimen.

Dose limiting toxicity is defined as any adverse reactions at level 3 or above that may be associated with CART-meso within 4 weeks after infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Autologous T-cells Redirected to Mesothelin With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CART-meso cells
A single dose of CART-meso T cells will be administered intravenously.The dose is 1-3×10^7/m^2 CART positive cells(chort 1)or 1-3×10^8/m^2 CART positive cells(chort 2).
Biological: CART-meso cells
CART-meso is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m^2 of cyclophosphamide, which will be administered according to standard procedures, Thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects.




Primary Outcome Measures :
  1. Safety of CART-meso infusion: number of adverse events [ Time Frame: 60 months ]
    Number of Adverse Events evaluated with NCI CTC AE, version 4.0[Safety evaluation]


Secondary Outcome Measures :
  1. Clinical response of CART-meso [ Time Frame: 60 months ]
    Number of patients with tumor response including overal remission ,complete ression,progression-free survival,progressive disease ,etc.

  2. CAR-T cell detection [ Time Frame: 60 months ]
    Detection of transferred T cells in peripheral blood or bone marrow using multi-parameter flow cytometer.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Unresectable or metastatic pancreatic cancer
  • Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease
  • 18 - 70 years of age
  • ECOG performance status of 0 or 1
  • Life expectancy greater than 3 months
  • Satisfactory organ and bone marrow function
  • Meets blood coagulation parameters
  • Male and Female subjects of reproductive potential agree to use approved contraceptive methods

Exclusion Criteria:

  • Participation in a therapeutic investigational study within 4 weeks prior to the screening visit
  • Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion
  • Active invasive cancer other than pancreatic cancer
  • HIV, HCV, or HBV infections
  • Active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement
  • Ongoing or active infection
  • Planned concurrent treatment with systemic high dose corticosteroids
  • Patients requiring supplemental oxygen therapy
  • Prior therapy with gene modified cells
  • Previous experimental therapy with SS1 moiety, murine or chimeric antibodies
  • History of allergy to murine proteins
  • History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
  • Clinically significant pericardial effusion, CHF, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study
  • 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): NCT03638193


Contacts
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Contact: Hongling ZHANG, PhD (+86)0755-86387905 hl.zhang@bindebio.com

Locations
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China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Jinfei CHEN, MD, PhD    (+86)18951670922      
Principal Investigator: Jinfei CHEN, MD, PhD         
Sponsors and Collaborators
Shenzhen BinDeBio Ltd.
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Jinfei CHEN, MD, PhD The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: Shenzhen BinDeBio Ltd.
ClinicalTrials.gov Identifier: NCT03638193    
Other Study ID Numbers: 2017NJYY-Meso
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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