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

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CART-meso cells

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CART-meso cells

Arm Description

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).

Outcomes

Primary Outcome Measures

Safety of CART-meso infusion: number of adverse events

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

Secondary Outcome Measures

Clinical response of CART-meso

Number of patients with tumor response including overal remission ,complete ression,progression-free survival，progressive disease ,etc.

CAR-T cell detection

Detection of transferred T cells in peripheral blood or bone marrow using multi-parameter flow cytometer.

Full Information

NCT ID

NCT03638193

First Posted

November 14, 2017

Last Updated

February 3, 2021

Sponsor

Shenzhen BinDeBio Ltd.

Collaborators

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03638193

Brief Title

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

Official Title

Study of Autologous T-cells Redirected to Mesothelin With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 11, 2018 (Actual)

Primary Completion Date

February 1, 2022 (Anticipated)

Study Completion Date

February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen BinDeBio Ltd.

Collaborators

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CART-meso cells

Arm Type

Experimental

Arm Description

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).

Intervention Type

Biological

Intervention Name(s)

CART-meso cells

Intervention Description

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 Measure Information:

Title

Safety of CART-meso infusion: number of adverse events

Description

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

Time Frame

60 months

Secondary Outcome Measure Information:

Title

Clinical response of CART-meso

Description

Number of patients with tumor response including overal remission ,complete ression,progression-free survival，progressive disease ,etc.

Time Frame

60 months

Title

CAR-T cell detection

Description

Detection of transferred T cells in peripheral blood or bone marrow using multi-parameter flow cytometer.

Time Frame

60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hongling ZHANG, PhD

Phone

(+86)0755-86387905

hl.zhang@bindebio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinfei CHEN, MD, PhD

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanjing First Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinfei CHEN, MD, PhD

Phone

(+86)18951670922

First Name & Middle Initial & Last Name & Degree

Jinfei CHEN, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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