Engineered immune cells and a virus team up against tough cancers

NCT ID NCT05057715

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Sep 2038

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Pancreatic adenocarcinoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.