Engineered immune cells and a virus team up against tough cancers
NCT ID NCT05057715
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This early-phase trial tests a new approach for people with advanced pancreatic or ovarian cancer that has not responded to standard treatments. Participants receive a single infusion of their own immune cells, engineered to recognize and attack cancer cells (huCART-meso), along with a virus (VCN-01) designed to help the immune cells work better inside tumors. The main goal is to see if this combination is safe and feasible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- huCART-meso cells and VCN-01 virus
- What this could lead to
- If successful, this combination could point toward a new treatment option for hard-to-treat pancreatic and ovarian cancers.
- What could go wrong
- This is an early phase 1 trial with only 13 participants, focused on safety. The approach may not work or could cause severe side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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13 people
The number who actually took part.
- Started
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Mar 2022
- Expected to finish
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Sep 2038
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with one of the following diagnoses: 1. Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma; OR 2. Persistent or recurrent serous epithelial ovarian cancer 2. Progression or intolerance to at least one prior standard of care chemotherapy for advanced stage disease. 3. Subjects must have measurable disease as defined by RECIST 1.1 criteria. 4. Patients ≥ 18 years of age. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Adequate organ and bone marrow function defined as: 1. Hemoglobin ≥ 9 g/dL 2. Platelets ≥ 75,000/µl 3. PT/INR and PTT ≤ 1.5 x ULN 4. Bilirubin ≤ 2.0 x ULN 5. Creatinine ≤ 1.5 x ULN 6. ALT/AST ≤ 5 x ULN (subjects with liver metastases) or ALT/AST ≤ 2.5 x ULN (subjects without liver metastases) 7. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air 8. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA 7. Provides written informed consent. 8. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in the protocol Exclusion Criteria: 1. Patients with known CNS metastases 2. Active invasive cancer other than the one of the two cancers targeted by 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. 3. Active hepatitis B or hepatitis C infection. 4. Chronic hepatitis C with a FibroScan score equivalent to fibrosis stage 2 (F2) or greater. 5. Patients with known cirrhosis. 6. Patients with ongoing or active infection. 7. Patients with a known history of Li Fraumeni syndrome or retinoblastoma protein pathway germinal deficiency. 8. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded. 9. Planned concurrent treatment with systemic high dose corticosteroids. Patients may be on a stable low dose of steroids (≤ 10mg equivalent of prednisone). Use of inhaled steroids is allowable. 10. Patients requiring supplemental oxygen therapy. 11. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40). 12. 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. 13. Pregnant or breastfeeding women. 14. RETIRED WITH PROTOCOL VERSION 5. 15. Patients with significant lung disease as follows: 1. 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. 2. Patients with radiographic and/or clinical evidence of active radiation pneumonitis. 3. 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.) 16. Patients with prior/ongoing treatment that will not accommodate washout requirements for immune checkpoint inhibitors
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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