Lung AdenocarcinomaPhase 1NCT03054298
CAR T Cells in Mesothelin Expressing Cancers
A Phase 1 study testing huCART-meso cells in people with Lung Adenocarcinoma and Ovarian Cancer, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Adenocarcinoma, Ovarian Cancer, Peritoneal Carcinoma
- What is being tested?
- huCART-meso cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2017to 30 Jul 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed cancer (one of the following):
- 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)
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- 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
- 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)
- 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:
- No concurrent treatment for the CNS disease
- No progression of CNS metastasis on MRI at screening scans
- No evidence of leptomeningeal disease or cord compression
- Subjects ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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.
- 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.
- Provide written informed consent.
- Subjects of reproductive potential must agree to use acceptable birth control methods.
Who cannot join
- 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
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- 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.
- Patients with ongoing or active infection.
- Dependence on systemic steroids or immunosupressant medications.
- Patients requiring supplemental oxygen therapy.
- Prior therapy with lentiviral gene modified cells.
- 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 which may worsen as a result of expected toxicities in this study. This determination will be made by a cardiologist if cardiac issues are suspected.
- Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. An indwelling drainage device placed prior to eligibility confirmation by physician / investigator is acceptable.
- Pregnant or breastfeeding women.
- EXCLUSION HAS BEEN RETIRED
- EXCLUSION HAS BEEN RETIRED
- Subjects with significant lung disease as follows:
- Subjects 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.
- Subjects with radiographic and/or clinical evidence of active radiation pneumonitis.
- Subjects 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase I Study of Human Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Cancers
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.
Read the detailed description
This is a Phase I study evaluating the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells with and without lymphodepleting chemotherapy.
- Cohort 1 (N=3-6): will receive a single dose of 1-3x10^7 huCARTmeso cells/m^2 on day 0 without any conditioning chemotherapeutic regimen.
- Cohort 2 (N=3-6): will receive a single dose of 1-3x10^7 huCARTmeso cells/m^2 on day 0, following a flat dose of 1 gram/m2 of cyclophosphamide administered 2-4 days prior to huCARTmeso cells (day -4 to day -2).
- Cohort 3 (N=3-6): will receive a single dose of 1-3x10^8 /m^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen. Cohort 3 permanently closed
- Cohort 4 subjects (N=3-6) will receive a single dose of 1-3x10^8 /m^2 lentiviral transduced huCART-meso cells on day 0, following a flat dose of 1 gram/m^2 of cyclophosphamide administered 2-4 days prior to huCART-meso cells (day -4 to day -2). Cohort 4 permanently closed
- Cohort 5 (N=up to 6): will receive a single dose of 1-3x10^7 huCARTmeso cells/m^2 on day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. The safety of this dose level has been established by Cohorts 1 and 2.
- Cohort 6 (N=up to 6): will receive a dose of 1-3x10^7 huCARTmeso cells/m^2 via IV infusion on Day 0, following a flat dose of 1 gram/m^2 of cyclophosphamide administered 2-4 days prior to huCART-meso cells (~Day -4 to -2). This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given between 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. Enrollment into Cohort 6 will occur in parallel with Cohort 5.
- Cohort 7 (N = up to 6): will receive a single dose of 1-3x10^7 huCART-meso cells/m^2 via intraperitoneal (i.p.) administration, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day given over 3 days by intravenous infusion. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the 1st infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
The Maximum Tolerated Dose (MTD) is defined as the dose at which 0-1 DLT occurs in 6 evaluable subjects tested within the dose range of this study. The maximum tolerated dose has been established as 1-3x10^7 huCARTmeso cells/m^2.
Adverse events will be collected and evaluated during the protocol specified adverse event reporting period
- Conditions
- Lung Adenocarcinoma, Ovarian Cancer, Peritoneal Carcinoma, Fallopian Tube Cancer, Mesotheliomas Pleural, Mesothelioma Peritoneum
- Being tested
- huCART-meso cells
- Medical subject headings
- Adenocarcinoma of Lung, Ovarian Neoplasms, Fallopian Tube Neoplasms, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
huCART-meso cellsBiological
Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Single dose of 1-3x10^7 huCARTmeso cells/m^2 Receives: Biological: huCART-meso cells |
| Cohort 2 | Active comparator | Cyclophosphamide 1 gram/m^2 administered 2-4 days prior to a single dose of 1-3x10^7 huCARTmeso cells/m^2 Receives: Biological: huCART-meso cells |
| Cohort 3 | Active comparator | PERMANENTLY CLOSED Receives: Biological: huCART-meso cells |
| Cohort 4 | Active comparator | PERMANENTLY CLOSED Receives: Biological: huCART-meso cells |
| Cohort 5 | Active comparator | Single dose of 1-3x10^7 huCART-meso cells/m^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. Receives: Biological: huCART-meso cells |
| Cohort 6 | Active comparator | Cyclophosphamide 1 gram/m^2 administered 2-4 days prior to dose of 1-3x10^7 huCART-meso cells/m^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. Receives: Biological: huCART-meso cells |
| Cohort 7 | Active comparator | Cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10^7 huCART-meso cells/m^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. Receives: Biological: huCART-meso cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Measured: 7 years
Secondary outcomes (3)
Progression-free Survival
Progression is defined using RECIST V1.1 - at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
Measured: 7 years
Overall Survival
Measured: 7 years
Objective Response Rate
Objective response rate is the proportion of subjects in the efficacy-evaluable set with radiologically confirmed measurable disease at baseline, who achieved partial response (PR) or better after infusion as determined by RECIST 1.1. Missing or non-evaluable time points will not be included.
Per RECIST 1.1, a complete response is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm." A partial response is defined as "at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start6 Apr 2017
- Primary completion9 Nov 2023
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Tmunity Therapeutics, a wholly owned subsidiary of Kite Pharma (a Gilead company)
- Responsible party
- Sponsor
- Investigators
- Janos L Tanyi, MD, PhD, Principal investigator, University of Pennaylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054298
- Sponsor's protocol ID
- 826085 (UPCC 02916)
- Status last verified
- Apr 2025
- First submitted
- 9 Feb 2017
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Human Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Cancers
- ClinicalTrials.gov ID
- NCT03054298
- Acronym / sponsor ID
- 826085 (UPCC 02916)
- Conditions
- Lung Adenocarcinoma, Ovarian Cancer, Peritoneal Carcinoma, Fallopian Tube Cancer, Mesotheliomas Pleural, Mesothelioma Peritoneum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Tmunity Therapeutics, a wholly owned subsidiary of Kite Pharma (a Gilead company)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase I study evaluating the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells with and without lymphodepleting chemotherapy.
- Cohort 1 (N=3-6): will receive a single dose of 1-3x10^7 huCARTmeso cells/m^2 on day 0 without any conditioning chemotherapeutic regimen.
- Cohort 2 (N=3-6): will receive a single dose of 1-3x10^7 huCARTmeso cells/m^2 on day 0, following a flat dose of 1 gram/m2 of cyclophosphamide administered 2-4 days prior to huCARTmeso cells (day -4 to day -2).
- Cohort 3 (N=3-6): will receive a single dose of 1-3x10^8 /m^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen. Cohort 3 permanently closed
- Cohort 4 subjects (N=3-6) will receive a single dose of 1-3x10^8 /m^2 lentiviral transduced huCART-meso cells on day 0, following a flat dose of 1 gram/m^2 of cyclophosphamide administered 2-4 days prior to huCART-meso cells (day -4 to day -2). Cohort 4 permanently closed
- Cohort 5 (N=up to 6): will receive a single dose of 1-3x10^7 huCARTmeso cells/m^2 on day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. The safety of this dose level has been established by Cohorts 1 and 2.
- Cohort 6 (N=up to 6): will receive a dose of 1-3x10^7 huCARTmeso cells/m^2 via IV infusion on Day 0, following a flat dose of 1 gram/m^2 of cyclophosphamide administered 2-4 days prior to huCART-meso cells (~Day -4 to -2). This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given between 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. Enrollment into Cohort 6 will occur in parallel with Cohort 5.
- Cohort 7 (N = up to 6): will receive a single dose of 1-3x10^7 huCART-meso cells/m^2 via intraperitoneal (i.p.) administration, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day given over 3 days by intravenous infusion. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the 1st infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
The Maximum Tolerated Dose (MTD) is defined as the dose at which 0-1 DLT occurs in 6 evaluable subjects tested within the dose range of this study. The maximum tolerated dose has been established as 1-3x10^7 huCARTmeso cells/m^2.
Adverse events will be collected and evaluated during the protocol specified adverse event reporting period
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Biological: huCART-meso cellsSingle dose of 1-3x10^7 huCARTmeso cells/m^2 |
| Cohort 2 | Active comparator | Biological: huCART-meso cellsCyclophosphamide 1 gram/m^2 administered 2-4 days prior to a single dose of 1-3x10^7 huCARTmeso cells/m^2 |
| Cohort 3 | Active comparator | Biological: huCART-meso cellsPERMANENTLY CLOSED |
| Cohort 4 | Active comparator | Biological: huCART-meso cellsPERMANENTLY CLOSED |
| Cohort 5 | Active comparator | Biological: huCART-meso cellsSingle dose of 1-3x10^7 huCART-meso cells/m^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. |
| Cohort 6 | Active comparator | Biological: huCART-meso cellsCyclophosphamide 1 gram/m^2 administered 2-4 days prior to dose of 1-3x10^7 huCART-meso cells/m^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. |
| Cohort 7 | Active comparator | Biological: huCART-meso cellsCyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10^7 huCART-meso cells/m^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Histologically confirmed cancer (one of the following):
- Note: Cohorts 3 and 4 permanently closed
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| huCART-meso cellsIntravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion.. | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Time frame: 7 years
3 secondary outcomes
Progression-free Survival
Time frame: 7 years
Overall Survival
Time frame: 7 years
Objective Response Rate
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janos L Tanyi, MD, PhD principal investigator
University of Pennaylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing huCART-meso cells in people with Lung Adenocarcinoma and 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 34 inclusion and 22 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: finished, as of the sponsor's last update on 29 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2025.