Metastatic Pancreatic (Ductal) AdenocarcinomaPhase 1NCT02159716
CART-meso in Mesothelin Expressing Cancers
A Phase 1 study testing CART-meso in people with Metastatic Pancreatic (Ductal) Adenocarcinoma and Epithelial Ovarian Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
Phase I study to establish safety and feasibility of intravenously administered lentiviral transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian cancer, or pleural mesothelioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic (Ductal) Adenocarcinoma, Epithelial Ovarian Cancer, Malignant Epithelial Pleural Mesothelioma
- What is being tested?
- CART-meso
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed cancer (one of the following):
- Metastatic pancreatic adenocarcinoma.
- Persistent or recurrent serous epithelial ovarian cancer or primary peritoneal carcinoma
- Malignant pleural mesothelioma (histologically confirmed epithelial)
- Failure of at least one prior standard of care chemotherapy for advanced stage disease.
- Subjects must have measureable disease as defined by RECIST 1.1 criteria or modified RECIST criteria.
Show all 14Show fewer
- Patients > 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy > 3 months.
- Satisfactory organ and bone marrow function as defined by the following (of note, the minimal blood counts should be in the absence of transfusion or cytokine support):
- Absolute neutrophil count > 1,000/μl ii. Platelets >75,000/μl iii. Hemoglobin > 9 g/dL iv. Bilirubin < 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor v. Creatinine < 1.5x the institutional normal upper limit vi. Albumin ≥2 vii. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5x the institutional normal upper limit viii. Cardiac ejection fraction of >55% as measured by resting echocardiogram, with no significant pericardial effusion.
- Blood coagulation parameters: PT such that international normalized ratio (INR) is ≤ 1.5 and a PTT < 1.2 time the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters.
- Ability to understand and the willingness to provide written informed consent.
- Male and Female subjects of reproductive potential agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) and abstain from other methods of conception during the study and for 6 months following the study cell infusion or proof of sterility.
Who cannot join
- Sarcomatoid MPM histology which is known in the literature to not express mesothelin; biphasic MPM is also excluded.
- Participated in any other trial in which receipt of an investigational study drug occurred within 28 days prior to enrollment and anticipated treatment with another investigational product while on study. This refers to non-commercially approved investigational drugs different than those used in this protocol.
- Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion of CART-meso cells.
- Active invasive cancer other than the one of the three cancers in this study. Patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder and prostate cancer with PSA level < 1.0) are not excluded.CART-meso in mesothelin expressing cancers
- HIV, HCV, or HBV infections
- Active autoimmune disease (including but not limited to: systemic lupus erythromatosis, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) requiring immunosuppressive therapy within the past 4 weeks, with exception of thyroid replacement.
Show all 16Show fewer
- Patients with ongoing or active infection.
- Planned concurrent treatment with systemic high dose corticosteroids. Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions.
- Patients requiring supplemental oxygen therapy.
- Prior therapy with gene modified cells.
- Previous experimental therapy with SS1 moiety, murine or chimeric antibodies (human and humanized antibodies are allowed).
- History of allergy to murine proteins
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
- Any clinically significant pericardial effusion; CHF (NY Heart Association Grade II-IV) or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study. This determination will be made by a cardiologist.
- Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. An indwelling drainage device placed prior to enrollment is acceptable.
- Pregnant or breastfeeding women. Female study participants of reproductive potential must have a negative urine pregnancy test of enrollment. A serum pregnancy test will be performed within 2 weeks before infusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase I Study of Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Cancers
Phase I study to establish safety and feasibility of intravenously administered lentiviral transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort 3 and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we will dose deescalate by 10-fold.
- Conditions
- Metastatic Pancreatic (Ductal) Adenocarcinoma, Epithelial Ovarian Cancer, Malignant Epithelial Pleural Mesothelioma
- Being tested
- CART-meso
- Keywords
- Subjects
- Medical subject headings
- Adenocarcinoma, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-mesoBiological
CART-meso are autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor SS1 fused to the 4-1BB and CD3ζ signaling domains.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Pancreatic (ductal) adenocarcinoma (PDA) | Experimental | Not described Receives: Biological: CART-meso |
| Serious Epithelial Ovarian Cancer | Experimental | Not described Receives: Biological: CART-meso |
| Malignant Epithelial Pleaural Mesothelioma | Experimental | Not described Receives: Biological: CART-meso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic (Ductal) AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Haas, MD, Principal investigator, Ambramson Cancer Center of the University of PennsylvaniaAndrew Haas, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159716
- Sponsor's protocol ID
- UPCC 31213, 819826
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2014
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Cancers
- ClinicalTrials.gov ID
- NCT02159716
- Acronym / sponsor ID
- UPCC 31213, 819826
- Conditions
- Metastatic Pancreatic (Ductal) Adenocarcinoma, Epithelial Ovarian Cancer, Malignant Epithelial Pleural Mesothelioma
- Keywords
- Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I study to establish safety and feasibility of intravenously administered lentiviral transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort 3 and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we will dose deescalate by 10-fold.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metastatic Pancreatic (ductal) adenocarcinoma (PDA) | Experimental | Biological: CART-meso |
| Serious Epithelial Ovarian Cancer | Experimental | Biological: CART-meso |
| Malignant Epithelial Pleaural Mesothelioma | Experimental | Biological: CART-meso |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed cancer (one of the following):
- Failure of at least one prior standard of care chemotherapy for advanced stage disease.
- Subjects must have measureable disease as defined by RECIST 1.1 criteria or modified RECIST criteria.
- Patients > 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (16 listed)
- Sarcomatoid MPM histology which is known in the literature to not express mesothelin; biphasic MPM is also excluded.
- Participated in any other trial in which receipt of an investigational study drug occurred within 28 days prior to enrollment and anticipated treatment with another investigational product while on study. This refers to non-commercially approved investigational drugs different than those used in this protocol.
- Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion of CART-meso cells.
- Active invasive cancer other than the one of the three cancers in this study. Patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder and prostate cancer with PSA level < 1.0) are not excluded.CART-meso in mesothelin expressing cancers
- HIV, HCV, or HBV infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CART-mesoCART-meso are autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor SS1 fused to the 4-1BB and CD3ζ signaling domains. | Biological | Malignant Epithelial Pleaural Mesothelioma, Metastatic Pancreatic (ductal) adenocarcinoma (PDA), Serious Epithelial Ovarian Cancer |
Primary outcome
Number of Adverse Events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
Related trials for Metastatic Pancreatic (Ductal) Adenocarcinoma
Not yet recruitingPhase 1/2
TNG462-C103: Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Vopimetostat in Combination With ERAS-0015 in PDAC and NSCLC Patients
PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingPhase 1/2
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Haas, MD principal investigator
Ambramson Cancer Center of the University of Pennsylvania
Andrew Haas, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CART-meso in people with Metastatic Pancreatic (Ductal) Adenocarcinoma and Epithelial Ovarian Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.