NCT03638193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable pancreatic-cancer

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

July 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

3.6 years

First QC Date

November 14, 2017

Last Update Submit

February 3, 2021

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety of CART-meso infusion: number of adverse events

    Number of Adverse Events evaluated with NCI CTC AE, version 4.0\[Safety evaluation\]

    60 months

Secondary Outcomes (2)

  • Clinical response of CART-meso

    60 months

  • CAR-T cell detection

    60 months

Study Arms (1)

CART-meso cells

EXPERIMENTAL

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

Interventions

CART-meso cellsBIOLOGICAL

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.

CART-meso cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Unresectable or metastatic pancreatic cancer
  • Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jinfei CHEN, MD, PhD

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongling ZHANG, PhD

CONTACT

(+86)0755-86387905hl.zhang@bindebio.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

August 20, 2018

Study Start

July 11, 2018

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

CN(1)