Your session is about to expire
← Back to Search
CAR T-cell Therapy
CAR T Cell Therapy for Mesothelioma
Phase 1
Waitlist Available
Led By Janos L Tanyi, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with asymptomatic CNS metastases that have been treated and meet specific criteria
Subjects must be ≥ 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial is to test if it is safe to give patients huCART-meso cells, which have been modified with a lentivirus, through IV or directly to the affected area. Lymphodepletion is the removal of lymphocytes.
Who is the study for?
Adults over 18 with certain advanced cancers (like lung adenocarcinoma, ovarian cancer) who've had at least one chemo treatment can join. They must be fairly active and healthy otherwise, not have serious heart or lung conditions, no HIV/Hepatitis B/C, and agree to birth control. Those with treated brain metastases meeting specific criteria may also qualify.Check my eligibility
What is being tested?
The trial is testing huCART-meso cells in patients with mesothelin expressing cancers. It's a Phase I study looking at the safety of these cells given through IV or directly into the tumor area, with some patients possibly having their immune systems temporarily weakened first.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal tissues (autoimmune-like), infusion reactions from the cell therapy itself, and typical risks associated with weakening of the immune system if lymphodepletion is part of treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain metastases have been treated and are not causing symptoms.
Select...
I am 18 or older and can care for myself with minimal assistance.
Select...
My cancer is confirmed and includes specific types like lung or ovarian cancer.
Select...
My cancer can be measured by specific medical criteria.
Select...
My organ and bone marrow functions are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Secondary outcome measures
Objective response rate
Overall survival
Progression-free survival
Trial Design
7Treatment groups
Active Control
Group I: Cohort 7Active Control1 Intervention
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.
Group II: Cohort 1Active Control1 Intervention
Single dose of 1-3x10^7 huCARTmeso cells/m^2
Group III: Cohort 4Active Control1 Intervention
PERMANENTLY CLOSED
Group IV: Cohort 3Active Control1 Intervention
PERMANENTLY CLOSED
Group V: Cohort 2Active Control1 Intervention
Cyclophosphamide 1 gram/m^2 administered 2-4 days prior to a single dose of 1-3x10^7 huCARTmeso cells/m^2
Group VI: Cohort 5Active Control1 Intervention
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.
Group VII: Cohort 6Active Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Tmunity Therapeutics, a wholly owned subsidiary of Kite Pharma (a Gilead company)UNKNOWN
1 Previous Clinical Trials
18 Total Patients Enrolled
Tmunity TherapeuticsIndustry Sponsor
6 Previous Clinical Trials
84 Total Patients Enrolled
1 Trials studying Ovarian Cancer
16 Patients Enrolled for Ovarian Cancer
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,023 Total Patients Enrolled
10 Trials studying Ovarian Cancer
1,007 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have serious heart fluid buildup or heart conditions.I do not have severe lung disease.My brain metastases have been treated and are not causing symptoms.I am 18 or older and can care for myself with minimal assistance.I do not have any active cancer other than the one specified in the study.I have an autoimmune disease and have been on immunosuppressive therapy within the last four weeks.My cancer is confirmed and includes specific types like lung or ovarian cancer.I have cancer spread to the lining of my brain or spinal cord.I have brain metastases causing symptoms.I currently have an infection.I need extra oxygen to help me breathe.I have had treatment with gene-modified cells before.I rely on steroids or immunosuppressant drugs.I have fluid buildup that can't be drained with usual methods.My mesothelioma is either sarcomatoid or biphasic.I am HIV positive.My cancer can be measured by specific medical criteria.My organ and bone marrow functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 7
- Group 2: Cohort 1
- Group 3: Cohort 4
- Group 4: Cohort 3
- Group 5: Cohort 2
- Group 6: Cohort 5
- Group 7: Cohort 6
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available for participants in this experiment?
"Affirmative, the details on clinicaltrials.gov specify that this experiment is presently enrolling patients. The trial was originally posted on April 6th 2017 and its parameters were most recently revised March 8th 2022. 27 participants are needed from 1 site for successful completion of the trial."
Answered by AI
Has the FDA sanctioned Cohort 1?
"Due to the experimental nature of this Phase 1 trial, there is limited data on Cohort 1's safety and efficacy. Thus, our team at Power assessed their risk level as a score of 1."
Answered by AI
How many individuals are engaged in this clinical investigation?
"Affirmative, the clinical trial is still recruiting. It was originally advertised on April 6th 2017 and last updated March 8th 2022. The research seeks 27 subjects from a single location."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger