Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT02465983 |
Recruitment Status :
Terminated
(Lack of efficacy and funding to continue investigation)
First Posted : June 9, 2015
Last Update Posted : December 16, 2019
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Cancer | Biological: CART-meso-19 T cells Drug: Cyclophosphamide | Phase 1 |
Immunotherapy is a novel and promising approach for the treatment of solid tumors; immunotherapy with chimeric antigen receptor (CAR) T cells (CART cells) in particular has the potential advantage of targeted therapies that can invoke a rapid tumor response, and the advantage of long-lived responses that are the hallmark of engagement of the adaptive immune system such as memory T cells.
This is a single arm, open-label, phase I study to determine the safety and feasibility of combination CART-meso cells (autologous T cells lentivirally transduced to express anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains) and CART19 cells (autologous T cells lentivirally transduced to express a humanized anti-CD19 scFv fused to TCRζ and 4-1BB costimulatory domains) in patients with pancreatic cancer following lymphodepletion with cyclophosphamide.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study of Autologous T-cells Redirected to Mesothelin and CD19 With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer |
Study Start Date : | May 2015 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
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Experimental: CART-meso-19 T cells
A single dose of CART-meso-19 T cells (combination therapy with CART-meso and CART19 cells) will be administered intravenously as two separate infusions. The dose is 1-3x107/m2 (Cohort 1) or 1-3x108/m2 (Cohort 2) CART positive cells. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures in the outpatient setting.
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Biological: CART-meso-19 T cells
A single dose of CART-meso-19 cells (combination therapy with CART-meso and CART19 cells) will be administered intravenously as two separate infusions. The dose is 1-3x107/m2 (Cohort 1) or 1-3x108/m2 (Cohort 2) CART positive cells. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures in the outpatient setting. Patients will receive CART cell treatment on an outpatient basis. Drug: Cyclophosphamide A single dose of chemotherapy to be administered prior to dosing of the CART-meso-19 cells |
- Safety of IV administration of CART-meso-19 with cyclophosphamide as lymphodepleting chemotherapy in patients with pancreatic cancer using the NCI CTCAE v4.03 criteria [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 years of age and older
- 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

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): NCT02465983
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94158 |
Study Director: | Gabriela Plesa | University of Pennsylvania | |
Principal Investigator: | Andrew Ko | University of California, San Francisco |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT02465983 |
Other Study ID Numbers: |
UPCC 19214, 821275 UPCC 19214 ( Other Identifier: University of Pennsylvania Cancer Center ) UCSF CC144520 ( Other Identifier: University of California San Francisco Cancer Center ) |
First Posted: | June 9, 2015 Key Record Dates |
Last Update Posted: | December 16, 2019 |
Last Verified: | December 2019 |
Pancreatic Cancer CAR / CART T cells Immunotherapy |
Gene therapy Redirected T cells Autologous T cells |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Cyclophosphamide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |