CompletedPhase 1NCT03054298
Official study title

CAR T Cells in Mesothelin Expressing Cancers

Study summary

Phase I study to establish safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells with or without lymphodepletion.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedhuCART-meso cells

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 29, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Pennsylvania

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
University of Pennsylvania
Interventions being studied
Biological: huCART-meso cells
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 1. Histologically confirmed cancer (one of the following): 1. Cohorts 1-4 and Cohort 6 participants: \*\*Note: Cohorts 3 and 4 permanently closed\*\
  • Metastatic or recurrent lung adenocarcinoma.
  • Persistent or recurrent serous epithelial ovarian cancer or primary peritoneal carcinoma or fallopian tube carcinoma
  • Malignant pleural and peritoneal mesothelioma (histologically confirmed epithelial) 2. Cohort 5 participants: \*\*Note: As of 1-Feb-2021 lung adenocarcinoma patients are no longer being enrolled in this trial\*\
  • Metastatic or recurrent lung adenocarcinoma with documented pleural effusion
  • Persistent or recurrent serous epithelial ovarian cancer or primary peritoneal carcinoma or fallopian tube carcinoma with documented pleural effusion
  • Malignant pleural and peritoneal mesothelioma (histologically confirmed epithelial) with documented pleural effusion 3. Cohort 7 patients:
  • Persistent or recurrent serous epithelial ovarian cancer or primary peritoneal carcinoma or fallopian tube carcinoma with evidence of ascites
  • Malignant peritoneal mesothelioma (histologically confirmed epithelial) 2. CRITERIA HAS BEEN RETIRED 3. Failure of at least one prior standard of care chemotherapy for advanced stage disease. ALLOWANCE FOR PRIOR PD-1 or PDL-1 THERAPIES REMOVED. 4. Patients must have measurable disease as defined by RECIST 1.1 criteria or modified RECIST criteria (mesothelioma only). 5. Subjects with asymptomatic CNS metastases that have been treated (and are off steroids for the treatment of CNS disease) are allowed. They must meet the following at the time of enrollment: 1. No concurrent treatment for the CNS disease 2. No progression of CNS metastasis on MRI at screening scans 3. No evidence of leptomeningeal disease or cord compression 6. Subjects ≥ 18 years of age. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Satisfactory organ and bone marrow function as defined by the following:
  • Absolute neutrophil count ≥ 1,000/μl
  • Platelets ≥75,000/μl
  • Hemoglobin ≥ 8 g/dL
  • Direct bilirubin ≤ 2.0 mg/dl unless secondary to bile duct obstruction by tumor or Gilbert's syndrome with a direct bilirubin of less that 3.0 mg/dl is allowed.
  • Creatinine ≤ 1.5x the institutional normal upper limit
  • Albumin ≥ 2
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit
  • Cardiac ejection fraction of ≥40% as measured by resting echocardiogram, with no clinically significant pericardial effusion. 9. 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. 10. Provide written informed consent. 11. Subjects of reproductive potential must agree to use acceptable birth control methods.
Reasons someone may not be able to joinExclusion criteria

1. Sarcomatoid and biphasic mesothelioma. 2. Known leptomeningeal carcinomatosis or spinal cord compression. Screening for this is not required unless suspicious symptoms. 3. Subjects with symptomatic CNS metastases are excluded. 4.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 29, 2025. Always confirm current availability with the study team.

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