Pancreatic CancerPhase 1NCT03323944
CAR T Cell Immunotherapy for Pancreatic Cancer
A Phase 1 study testing huCART-meso cells in people with Pancreatic Cancer and Cancer of the Pancreas, run by University of Pennsylvania at 1 site in United States.
Trial summary
Phase I study to establish the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells in patients with histologically confirmed unresectable or metastatic pancreatic adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Cancer of the Pancreas
- What is being tested?
- huCART-meso cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 20 Feb 2025
- 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
- Patients with the following diagnoses:
- Cohorts 1 and -1: Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma
- Cohort 2: Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma; and either cytologically-proven ascites or known peritoneal disease on radiologic imaging.
- Cohort 3 - 4: Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma with liver metastases as confirmed by pathology or radiographic imaging.
- INCLUSION CRITERIA HAS BEEN RETIRED
- Prior treatment requirements:
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- Cohorts 1 - 3: Failure of at least one prior standard of care chemotherapy for advanced stage disease.
- Cohort 4: At lease stable disease on the first-line standard of care chemotherapy for advanced stage disease.
- Cohorts 1-3 and -1: Subjects must have measurable disease as defined by RECIST 1.1 criteria.
- Patients ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Satisfactory organ and bone marrow function as defined by the following:
- Absolute neutrophil count ≥ 1,000/μl ii. Platelets ≥75,000/μl iii. Hemoglobin ≥ 8 g/dL iv. Direct bilirubin ≤ 2.0 mg/dl unless the subject has Gilbert's disease syndrome (≤ 3.0 mg.dl) 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 ≥40% as measured by resting echocardiogram, with no clinically 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.
- Provides written informed consent.
- Subjects of reproductive potential must agree to use acceptable birth control methods
Who cannot join
- EXCLUSION CRITERIA HAS BEEN RETIRED
- Active invasive cancer other than pancreatic adenocarcinoma. Patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder cancer, or prostate cancer with PSA level < 1.0) are not excluded.
- HIV infection
- Active hepatitis B or hepatitis C infection
- Active autoimmune disease (including but not limited to: systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) requiring immunosuppressive therapy within 4 weeks prior to eligibility confirmation by physician-investigator, with the exception of thyroid replacement.
- Patients with ongoing or active infection.
Show all 22Show fewer
- Dependence on systemic steroids or immunosuppressant medications.
- Patients requiring supplemental oxygen therapy.
- Prior therapy with lentiviral gene modified cells.
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
- Any clinically significant pericardial effusion, Class II-IV cardiovascular disability according to the New York Heart Association Classification or other 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 if cardiac issues are suspected.
- Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. An indwelling drainage device placed prior to eligibility confirmation by physician-investigator is acceptable.
- Pregnant or breastfeeding women.
- EXCLUSION CRITERIA HAS BEEN RETIRED
- EXCLUSION CRITERIA HAS BEEN RETIRED
- Patients with significant lung disease as follows:
- <!-- -->
- Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and/or evidence of extensive bilateral parenchymal metastatic burden. Note: "Greater than lobar" = "in more than 1 lobe".
- Patients with radiographic and/or clinical evidence of active radiation pneumonitis.
- Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc)
- Patients with radiographic evidence of significant pleural effusion that is not readily amenable to minimally invasive drainage.
- 17. Cohort 3 and 4 Subjects Only: Patients with a contraindication to IV contrast.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase I Study of Human Chimeric Antigen Receptor Modified T Cells (CAR T Cells) in Patients With Pancreatic Cancer
Phase I study to establish the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells in patients with histologically confirmed unresectable or metastatic pancreatic adenocarcinoma
Read the detailed description
This is a Phase I study evaluating the safety and feasibility of lentiviral transduced huCART-meso cells in up to 4 cohorts. Lymphodepleting chemotherapy will not be utilized as part of the planned dosing strategy.
- Cohort 1 (N=3-6): will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intravenous infusion.
- Enrollment into Cohort 1 will be paused after the 3rd subject is infused to allow for a formal DLT assessment (performed by the Clinical PI and Medical Director) and DSMB review. If 1 DLT/3 subjects occurs in Cohort 1, the Sponsor (with guidance from the DSMB), will determine whether the study will enroll an additional 3 subjects at this dose level to further establish safety via intravenous infusion, or advance to Cohorts 2 and 3 to explore local delivery of huCART-meso cells at the same dose level. If 0 DLT/3 subjects or 1 DLT/6 subjects occurs at any time, the study may advance to Cohorts 2 and 3.
- If 2 DLTs occur at this dose level at any time, enrollment in Cohort 1 will be stopped and the dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2 (Cohort -1).
- The infusions in Cohort 1 will be staggered by at least 28 days to allow for the assessment of DLTs for cohort progression, expansion, or dose de-escalation.
In the event that 2 DLTs occur among subjects enrolled in Cohort 1, then enrollment in Cohort 1 will be stopped and the dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2. This de-escalated cohort will be designated Cohort -1.
- Cohort -1 (N=3-6): will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0. Up to 6 subjects will be infused in Cohort -1 if ≤ 1 DLT occurs.
If 0 DLT/3 subjects or 1 DLT/6 subjects occurs in Cohort 1, the study will advance to allow for additional cohorts to be explored.
- Cohorts 2 and 3. Enrollment into these additional cohorts may occur in parallel, however infusions will be staggered as follows to allow for monitoring/assessment of toxicities:
- Cohorts 2 and 3: As of Protocol Amendment V7, Infusion #1/Day 0 for the next 6 subjects in Cohorts 2 and 3 must be staggered by at least 28 days; This includes a minimum of 3 evaluable subjects in Cohort 2 and 3 evaluable subjects in Cohort 3. A DLT assessment will be performed after the 3rd evaluable subject in each cohort reaches the Day 21 safety follow-up visit. If no DLTs are identified in the 1st three evaluable subjects in both Cohorts 2 + 3, subsequent infusions of new subjects within either cohort may occur in parallel; however, no more than two new subjects may be infused within a 14-day period, irrespective of cohort assignment. If both cohorts have not yet infused 3 evaluable subjects without a DLT, all infusions will continue to be staggered by 28 days until this provision is met.
- Cohort 4: Infusion #1/Day 0 for the first 3 subjects in Cohort 4 must be staggered by at least 28 days. A DLT assessment will be performed after the 3rd evaluable subject in this cohort reaches the Day 21 safety follow-up visit. If no DLTs are identified in the 1st three evaluable subjects, subsequent infusions of new subjects may occur in parallel, however no more than two new subjects may be infused within a 14-day period. If 1 DLT is identified in the 1st three evaluable subjects, Infusion #1 for all subsequent subjects will continue to be staggered by at least 28 days and DLT assessments will be performed after each evaluable subject reaches the Day 21 safety follow-up visit.
- Cohort 2 Participants (N = Up to 6): will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intraperitoneal (i.p.) administration. The initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions.
Cohort 2 is prematurely closed. This closure is the result of feasibility concerns specific to the clinical/disease status of these patients at this stage of their treatment.
- Cohort 3 Participants (N = Up to 6): will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intrahepatic delivery (Hepatic Arterial Infusion). The initial intrahepatic infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions.
Cohort 3 is prematurely closed. This closure is the result of feasibility concerns specific to the clinical/disease status of these patients at this stage of their treatment.
- Cohort 4 Participants (N = Up to 6): will allow for the administration of lentiviral transduced huCART-meso cells during 1st line standard of care chemotherapy. A single dose of 1-3x10^7/m^2 huCART-meso cells will be administered on day 0 via intrahepatic delivery (Hepatic Arterial Infusion), following a 1 week washout after standard of care chemotherapy. This initial intrahepatic infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet all eligibility to receive additional infusions. Additional doses of standard of care chemotherapy may also be administered between huCART-meso infusions at the physician-investigator's discretion, as long as the required washout windows are appropriately adhered to. huCART-meso infusions may also be discontinued at any time in favor of resuming standard of care chemotherapy at the physician-investigator's discretion.
Adverse events will be collected and evaluated during the protocol specified adverse event reporting period. Subjects will be continually evaluated for dose-limiting toxicities (DLT). In the event of 2 DLTs in a specific cohort, additional enrollment and treatment activity will be paused to allow for further investigation.
- Conditions
- Pancreatic Cancer, Cancer of the Pancreas
- Being tested
- huCART-meso cells
- Keywords
- metastatic adenocarcinoma, pancreas
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
huCART-meso cellsBiological
Intravenous administration or local delivery of lentiviral transduced huCART-meso cells.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: huCART-meso cells via intravenous infusion (IV). | Experimental | Subjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intravenous infusion. Receives: Biological: huCART-meso cells |
| Cohort -1: low dose huCART-meso cells via intravenous infusion | Experimental | In the event that 2 DLTs occur among subjects enrolled in Cohort 1, then enrollment in Cohort 1 will be stopped and the dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2. Subjects will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0. Receives: Biological: huCART-meso cells |
| Cohort 2 - huCART meso cells via intraperitoneal infusion (IP) | Experimental | Permanently closed Receives: Biological: huCART-meso cells |
| Cohort 3 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion) | Experimental | Permanently closed Receives: Biological: huCART-meso cells |
| Cohort 4 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion) | Experimental | Subjects will receive a single dose of of 1-3x10^7 cells/m^2 lentiviral transduced huCART-meso cells on day 0 following a minimum 1 week washout from standard care chemotherapy. This initial intrahepatic infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. Receives: Biological: huCART-meso cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study subjects with treatment-related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: 2 years
Secondary outcomes (3)
Progression-free survival (PFS)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Objective response rate
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 posted27 Oct 2017
- Study start15 Sep 2017
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark O'Hara, MD, Principal investigator, Assistant Professor of Medicine, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323944
- Sponsor's protocol ID
- 827644 (UPCC 14217)
- Status last verified
- Jan 2026
- First submitted
- 19 Oct 2017
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Aznar MA, Good CR, Barber-Rotenberg JS, Agarwal S, Wilson W, Watts A, Zhang Z, Gonzales D, Donahue G, Hwang WT, Rennels AK, Rech AJ, Kuramitsu S, Huang H, Glastad KM, Alexander KA, Plesa G, Dowd E, Brennan A, Siegel DL, Tanyi J, Haas A, Torigian DA, Nadolski G, Gonzalez VE, Hexner EO, Fraietta JA, Jadlowsky JK, Young RM, Berger SL, June CH, O'Hara MH. Clinical and molecular dissection of CAR T cell resistance in pancreatic cancer. Cell Rep Med. 2025 Sep 16;6(9):102301. doi: 10.1016/j.xcrm.2025.102301. Epub 2025 Aug 18.
PubMed 40829595
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Human Chimeric Antigen Receptor Modified T Cells (CAR T Cells) in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03323944
- Acronym / sponsor ID
- 827644 (UPCC 14217)
- Conditions
- Pancreatic Cancer, Cancer of the Pancreas
- Keywords
- metastatic adenocarcinoma, pancreas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 27 Oct 2017 (actual)
- 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 the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells in patients with histologically confirmed unresectable or metastatic pancreatic adenocarcinoma
Detailed description
This is a Phase I study evaluating the safety and feasibility of lentiviral transduced huCART-meso cells in up to 4 cohorts. Lymphodepleting chemotherapy will not be utilized as part of the planned dosing strategy.
- Cohort 1 (N=3-6): will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intravenous infusion.
- Enrollment into Cohort 1 will be paused after the 3rd subject is infused to allow for a formal DLT assessment (performed by the Clinical PI and Medical Director) and DSMB review. If 1 DLT/3 subjects occurs in Cohort 1, the Sponsor (with guidance from the DSMB), will determine whether the study will enroll an additional 3 subjects at this dose level to further establish safety via intravenous infusion, or advance to Cohorts 2 and 3 to explore local delivery of huCART-meso cells at the same dose level. If 0 DLT/3 subjects or 1 DLT/6 subjects occurs at any time, the study may advance to Cohorts 2 and 3.
- If 2 DLTs occur at this dose level at any time, enrollment in Cohort 1 will be stopped and the dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2 (Cohort -1).
- The infusions in Cohort 1 will be staggered by at least 28 days to allow for the assessment of DLTs for cohort progression, expansion, or dose de-escalation.
In the event that 2 DLTs occur among subjects enrolled in Cohort 1, then enrollment in Cohort 1 will be stopped and the dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2. This de-escalated cohort will be designated Cohort -1.
- Cohort -1 (N=3-6): will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0. Up to 6 subjects will be infused in Cohort -1 if ≤ 1 DLT occurs.
If 0 DLT/3 subjects or 1 DLT/6 subjects occurs in Cohort 1, the study will advance to allow for additional cohorts to be explored.
- Cohorts 2 and 3. Enrollment into these additional cohorts may occur in parallel, however infusions will be staggered as follows to allow for monitoring/assessment of toxicities:
- Cohorts 2 and 3: As of Protocol Amendment V7, Infusion #1/Day 0 for the next 6 subjects in Cohorts 2 and 3 must be staggered by at least 28 days; This includes a minimum of 3 evaluable subjects in Cohort 2 and 3 evaluable subjects in Cohort 3. A DLT assessment will be performed after the 3rd evaluable subject in each cohort reaches the Day 21 safety follow-up visit. If no DLTs are identified in the 1st three evaluable subjects in both Cohorts 2 + 3, subsequent infusions of new subjects within either cohort may occur in parallel; however, no more than two new subjects may be infused within a 14-day period, irrespective of cohort assignment. If both cohorts have not yet infused 3 evaluable subjects without a DLT, all infusions will continue to be staggered by 28 days until this provision is met.
- Cohort 4: Infusion #1/Day 0 for the first 3 subjects in Cohort 4 must be staggered by at least 28 days. A DLT assessment will be performed after the 3rd evaluable subject in this cohort reaches the Day 21 safety follow-up visit. If no DLTs are identified in the 1st three evaluable subjects, subsequent infusions of new subjects may occur in parallel, however no more than two new subjects may be infused within a 14-day period. If 1 DLT is identified in the 1st three evaluable subjects, Infusion #1 for all subsequent subjects will continue to be staggered by at least 28 days and DLT assessments will be performed after each evaluable subject reaches the Day 21 safety follow-up visit.
- Cohort 2 Participants (N = Up to 6): will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intraperitoneal (i.p.) administration. The initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions.
Cohort 2 is prematurely closed. This closure is the result of feasibility concerns specific to the clinical/disease status of these patients at this stage of their treatment.
- Cohort 3 Participants (N = Up to 6): will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intrahepatic delivery (Hepatic Arterial Infusion). The initial intrahepatic infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions.
Cohort 3 is prematurely closed. This closure is the result of feasibility concerns specific to the clinical/disease status of these patients at this stage of their treatment.
- Cohort 4 Participants (N = Up to 6): will allow for the administration of lentiviral transduced huCART-meso cells during 1st line standard of care chemotherapy. A single dose of 1-3x10^7/m^2 huCART-meso cells will be administered on day 0 via intrahepatic delivery (Hepatic Arterial Infusion), following a 1 week washout after standard of care chemotherapy. This initial intrahepatic infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet all eligibility to receive additional infusions. Additional doses of standard of care chemotherapy may also be administered between huCART-meso infusions at the physician-investigator's discretion, as long as the required washout windows are appropriately adhered to. huCART-meso infusions may also be discontinued at any time in favor of resuming standard of care chemotherapy at the physician-investigator's discretion.
Adverse events will be collected and evaluated during the protocol specified adverse event reporting period. Subjects will be continually evaluated for dose-limiting toxicities (DLT). In the event of 2 DLTs in a specific cohort, additional enrollment and treatment activity will be paused to allow for further investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: huCART-meso cells via intravenous infusion (IV). | Experimental | Biological: huCART-meso cellsSubjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intravenous infusion. |
| Cohort -1: low dose huCART-meso cells via intravenous infusion | Experimental | Biological: huCART-meso cellsIn the event that 2 DLTs occur among subjects enrolled in Cohort 1, then enrollment in Cohort 1 will be stopped and the dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2. Subjects will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0. |
| Cohort 2 - huCART meso cells via intraperitoneal infusion (IP) | Experimental | Biological: huCART-meso cellsPermanently closed |
| Cohort 3 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion) | Experimental | Biological: huCART-meso cellsPermanently closed |
| Cohort 4 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion) | Experimental | Biological: huCART-meso cellsSubjects will receive a single dose of of 1-3x10^7 cells/m^2 lentiviral transduced huCART-meso cells on day 0 following a minimum 1 week washout from standard care chemotherapy. This initial intrahepatic infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
Key exclusion criteria (22 listed)
- <!-- -->
- 17. Cohort 3 and 4 Subjects Only: Patients with a contraindication to IV contrast.
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 |
|---|---|---|
| huCART-meso cellsIntravenous administration or local delivery of lentiviral transduced huCART-meso cells. | Biological | Cohort -1: low dose huCART-meso cells via intravenous infusion, Cohort 1: huCART-meso cells via intravenous infusion (IV)., Cohort 2 - huCART meso cells via intraperitoneal infusion (IP), Cohort 3 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion), Cohort 4 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion) |
Primary outcome
Number of study subjects with treatment-related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Time frame: 2 years
3 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Objective response rate
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 40829595Aznar MA, Good CR, Barber-Rotenberg JS, Agarwal S, Wilson W, Watts A, Zhang Z, Gonzales D, Donahue G, Hwang WT, Rennels AK, Rech AJ, Kuramitsu S, Huang H, Glastad KM, Alexander KA, Plesa G, Dowd E, Brennan A, Siegel DL, Tanyi J, Haas A, Torigian DA, Nadolski G, Gonzalez VE, Hexner EO, Fraietta JA, Jadlowsky JK, Young RM, Berger SL, June CH, O'Hara MH. Clinical and molecular dissection of CAR T cell resistance in pancreatic cancer. Cell Rep Med. 2025 Sep 16;6(9):102301. doi: 10.1016/j.xcrm.2025.102301. Epub 2025 Aug 18.
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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.
Mark O'Hara, MD principal investigator
Assistant Professor of Medicine, 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 huCART-meso cells in people with Pancreatic Cancer and Cancer of the Pancreas, 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 16 inclusion and 22 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: stopped early, as of the sponsor's last update on 30 Jan 2026. 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 was stopped early (reason given: Administrative reasons). Results are not available in the source record.
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 study subjects with treatment-related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323944, which also lists 1 linked publication.
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 30 Jan 2026.