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

Shenzhen BinDeBio

Status: Unknown

Conditions: Pancreatic Cancer

Treatments: Biological: CART-meso cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03638193

2017NJYY-Meso

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CART-meso cells

Experimental group

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).

Treatment:

Biological: CART-meso cells