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Pancreatic CancerPhase 1NCT05057715

huCART-meso + VCN-01 in Pancreatic and Ovarian Cancer

A Phase 1 study testing VCN-01 and huCART-meso Cells in people with Pancreatic Cancer and Serous Ovarian Cancer, run by University of Pennsylvania at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single-center phase 1 study to evaluate the safety and feasibility of huCART-meso cells given in combination with VCN-01 in patients with unresectable or metastatic pancreatic adenocarcinoma and serous epithelial ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Serous Ovarian Cancer
What is being tested?
VCN-01 and huCART-meso Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
2 Mar 2022to 29 Apr 2026
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 one of the following diagnoses:
  • Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma; OR
  • Persistent or recurrent serous epithelial ovarian cancer
  • Progression or intolerance to at least one prior standard of care chemotherapy for advanced stage disease.
  • Subjects must have measurable disease as defined by RECIST 1.1 criteria.
  • Patients ≥ 18 years of age.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ and bone marrow function defined as:
  • Hemoglobin ≥ 9 g/dL
  • Platelets ≥ 75,000/µl
  • PT/INR and PTT ≤ 1.5 x ULN
  • Bilirubin ≤ 2.0 x ULN
  • Creatinine ≤ 1.5 x ULN
  • ALT/AST ≤ 5 x ULN (subjects with liver metastases) or ALT/AST ≤ 2.5 x ULN (subjects without liver metastases)
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
  • Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
  • Provides written informed consent.
  • Subjects of reproductive potential must agree to use acceptable birth control methods, as described in the protocol

Who cannot join

  • Patients with known CNS metastases
  • 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.
  • Active hepatitis B or hepatitis C infection.
  • Chronic hepatitis C with a FibroScan score equivalent to fibrosis stage 2 (F2) or greater.
  • Patients with known cirrhosis.
  • Patients with ongoing or active infection.
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  • Patients with a known history of Li Fraumeni syndrome or retinoblastoma protein pathway germinal deficiency.
  • Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
  • 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.
  • Patients requiring supplemental oxygen therapy.
  • 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.
  • Pregnant or breastfeeding women.
  • RETIRED WITH PROTOCOL VERSION 5.
  • 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.
  • 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 prior/ongoing treatment that will not accommodate washout requirements for immune checkpoint inhibitors

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase 1 Trial of Human Chimeric Antigen Receptor Modified T Cells (huCART-meso) Administered in Combination With VCN-01 in Patients With Pancreatic and Serous Epithelial Ovarian Cancer

This is a single-center phase 1 study to evaluate the safety and feasibility of huCART-meso cells given in combination with VCN-01 in patients with unresectable or metastatic pancreatic adenocarcinoma and serous epithelial ovarian cancer.

Read the detailed description

This is a Phase I study evaluating the safety and feasibility of lentiviral transduced huCARTmeso cells when given in combination with VCN-01.

Dose Finding Phase:

This study was initiated using a 3+3 dose (de)escalation design in order to explore the initial safety of these drugs when given in combination, as well as to establish the recommended expansion dose of VCN-01 in this setting.

Expansion Phase:

The trial was expanded to include two parallel treatment arms further exploring the dosing sequence and schedule of these two investigational products when given in combination.

Being tested
VCN-01, huCART-meso Cells
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VCN-01Biological

    Intravenous administration of VCN-01

  • huCART-meso CellsBiological

    Intravenous administration of huCART-meso cells

Study groups in NCT05057715
Study groupRoleWhat they receive
Cohort 1ExperimentalSingle dose of 3.3x10(12) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14.
Receives: Biological: VCN-01; Biological: huCART-meso Cells
Cohort 2ExperimentalSingle dose of 1x10(13) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14.
Receives: Biological: VCN-01; Biological: huCART-meso Cells
Cohort -1ExperimentalIn the event that 2 DLTs occur in Cohort 1, then enrollment in Cohort 1 will be stopped and Cohort -1 will be opened for evaluation. Enrolled subjects will receive a single dose of huCART-meso cells on Day 0 followed by a single dose of 3.3x10(12) vp of VCN-01 on Day 14.
Receives: Biological: VCN-01; Biological: huCART-meso Cells
Expansion Arm AExperimentalRecommended expansion dose of VCN-01 as a single IV infusion on Day 0, followed by a single dose of 5x10^7 huCART-meso cells on Day 7 (+3d) via IV infusion.
Receives: Biological: VCN-01; Biological: huCART-meso Cells
Expansion Arm BExperimentalSingle dose of 5x10^7 huCART-meso cells on Day 0 via IV infusion followed by the recommended expansion dose of VCN-01 as a single IV infusion on Day 7 (+3d).
Receives: Biological: VCN-01; Biological: huCART-meso Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Type, frequency, severity, and attribution of AEs/SAEs as assessed by CTCAE v 5.0

    Measured: 2 years

  2. Occurrence of dose-limiting toxicities.

    Measured: 2 years

  3. Recommended expansion dose of VCN-01 administered in combination with huCART-meso cells

    highest VCN-01 dose at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects

    Measured: 42 days after Infusion #1 (huCART-meso cells or VCN-01 dependent on cohort assignment)

  4. Occurrence of treatment-limiting toxicities (TLTs)

    Number of subjects who either a) receive huCARTmeso cells and VCN-01 as per their arm assignment, or b) have a TLT qualifying event after receipt of either VCN-01 or huCART-meso cells.

    Measured: 28 days after Infusion #1 (huCART-meso cells or VCN-01 dependent on arm assignment)

  5. Comparison of the safety profiles of the two treatment arms via descriptive analysis

    Measured: Up to 15 years post infusion

Secondary outcomes (6)

  1. Proportion of subjects enrolled who receive one or both of the intended study infusions

    In the Expansion Phase, the proportion of subjects in each treatment arm will be compared via descriptive analysis.

    Measured: 2 years

  2. Overall Response Rate (ORR)

    Measured: 15 years

  3. Best Overall Response (BOR)

    Measured: 15 years

  4. Duration of Response (DOR)

    Measured: 15 years

  5. Progression Free Survival (PFS)

    Measured: 15 years

  6. Overall Survival (OS)

    Measured: 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2021
  2. Study start2 Mar 2022
  3. Primary completion29 Apr 2026
  4. Study completion29 Apr 2026

Why it stopped: Sponsor decision

Resources

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
Model description
3+3
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05057715
Sponsor's protocol ID
UPCC# 03821, IND #27590
Status last verified
Oct 2026
First submitted
15 Sep 2021
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VCN-01 and huCART-meso Cells in people with Pancreatic Cancer and Serous 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 18 inclusion and 19 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 29 Oct 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: Sponsor decision). 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?

Type, frequency, severity, and attribution of AEs/SAEs as assessed by CTCAE v 5.0 (time frame: 2 years). The study lists 5 primary outcomes in all. 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 NCT05057715.

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 Oct 2026.

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