CompletedPhase 1

CAR T Cells in Mesothelin Expressing Cancers

United States65 participantsStarted 2017-04-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically confirmed cancer (one of the following):
✓. Cohorts 1-4 and Cohort 6 participants:
✓. Cohort 5 participants: \*\*Note: As of 1-Feb-2021 lung adenocarcinoma patients are no longer being enrolled in this trial\*\*
✓. Cohort 7 patients:
✓. CRITERIA HAS BEEN RETIRED
✓. Failure of at least one prior standard of care chemotherapy for advanced stage disease. ALLOWANCE FOR PRIOR PD-1 or PDL-1 THERAPIES REMOVED.
✓. Patients must have measurable disease as defined by RECIST 1.1 criteria or modified RECIST criteria (mesothelioma only).
✓. 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:

Exclusion criteria

✕. Sarcomatoid and biphasic mesothelioma.
✕. Known leptomeningeal carcinomatosis or spinal cord compression. Screening for this is not required unless suspicious symptoms.
✕. Subjects with symptomatic CNS metastases are excluded.
✕. EXCLUSION CRITERIA HAS BEEN RETIRED
✕. Active invasive cancer other than the one of the three cancers in this study. Subjects 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.
✕. 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 four (4) weeks prior to eligibility confirmation by physician-investigator, with the exception of thyroid replacement.

What they're measuring

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03

Timeframe: 7 years

Trial details

NCT IDNCT03054298

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-09

Results submitted2024-11-08

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