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CAR T-cell Therapy
CAR T-cell Therapy for Mesothelioma
Phase 1
Recruiting
Led By Roisin O'Cearbhaill, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with peritoneal mesothelioma with pleural involvement are eligible only if there is radiographic and pathologic confirmation of mesothelioma in the pleural cavity and ≥10% of the tumor expresses MSLN by IHC analysis
Chemotherapy, targeted therapy, or therapeutic radiotherapy must be completed at least 14 days before administration of T cells
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test a new targeted cancer treatment in people with a specific type of mesothelioma. The goal is to find the safest dose of the treatment.
Who is the study for?
Adults over 18 with mesothelioma who've had at least one treatment regimen, are not on high-dose steroids, and don't have other active cancers or certain heart/lung conditions. They must be in good physical condition (Karnofsky score ≥70%) and have a life expectancy of more than 4 months.Check my eligibility
What is being tested?
The trial is testing different doses of MSLN-targeted CAR-T cells to find the safest dose for treating mesothelioma. It's the first time this therapy, which includes an anti-PD1 component, is being used in humans.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to CAR T-cell activity, effects from cyclophosphamide like nausea and low blood counts, as well as general risks associated with immunotherapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My mesothelioma affects both the lining of my abdomen and lungs, confirmed by tests.
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I finished my chemotherapy, targeted therapy, or radiotherapy at least 14 days ago.
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My tumor is mostly epithelioid or mixed and tests positive for MSLN.
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I am 18 years old or older.
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I have undergone at least one treatment regimen.
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My cancer can be measured or seen on tests.
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I finished my cancer treatment at least a week ago.
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I am able to care for myself but may not be able to do active work.
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My diagnosis of mesothelioma has been confirmed through a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD of M28z1XXPD1DNR
Secondary outcome measures
overall response rate (ORR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Engineered Autologous T CellsExperimental Treatment2 Interventions
Following eligibility screening and enrollment, patients will undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMCs), to enable generation of M28z1XXPD1DNR. Following successful M28z1XXPD1DNR CAR T-cell manufacturing, patients will be reevaluated for eligibility. A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m2 will be administered 2-7 days before the infusion. A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. All patients will be monitored in the hospital for a minimum of 48 h following the administration of CAR T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cyclophosphamide
1994
Completed Phase 3
~8140
CAR T cells
2017
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,825 Total Patients Enrolled
Atara BiotherapeuticsIndustry Sponsor
12 Previous Clinical Trials
675 Total Patients Enrolled
Roisin O'Cearbhaill, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My mesothelioma affects both the lining of my abdomen and lungs, confirmed by tests.I can finish palliative radiotherapy 2 days before starting lymphodepletion.I have had treatment for blood cancer or lymphoid malignancy in the last 5 years.I am taking high doses of corticosteroids every day.Your blood tests need to show a certain level of white blood cells and platelets, and your liver and kidney function need to be within a certain range.I finished my chemotherapy, targeted therapy, or radiotherapy at least 14 days ago.I am currently being treated for another cancer.I haven't had a live vaccine 8 weeks before or won't for 100 days after starting treatment.I have previously undergone CAR T-cell therapy.My tumor is mostly epithelioid or mixed and tests positive for MSLN.I do not have severe heart or lung conditions, and my oxygen levels are normal without assistance.I am 18 years old or older.I have undergone at least one treatment regimen.My cancer can be measured or seen on tests.I finished my cancer treatment at least a week ago.It has been more than 28 days since my last major chest or belly surgery.I am able to care for myself but may not be able to do active work.I completed the CPI more than 21 days before my leukapheresis procedure.I have untreated brain metastases.I have not needed antibiotics for an infection in the last 7 days.All side effects from my past cancer treatments have mostly gone away.I have been treated for an autoimmune disease in the last year.My diagnosis of mesothelioma has been confirmed through a biopsy.You do not have any infectious diseases.You are expected to live for at least 4 more months from the time you are screened for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Engineered Autologous T Cells
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.
How many participants are currently enrolled in this research program?
"Unfortunately, this trial has reached its recruitment quota and is no longer accepting patients. Its listing was first added to clinicaltrials.gov on September 30th 2020 and the most recent edit occured on October 10th 2022. If you are looking for alternative studies, there are currently 152 trials recruiting participants with malignant pleural mesothelioma and 816 that accept those seeking CAR T cells treatments."
Answered by AI
Could you please provide a synopsis of past experiments involving CAR T cells?
"Currently, 816 live clinical trials are exploring the efficacy of CAR T cell therapies with 154 studies in their final phase. While Philadelphia is a hub for this medical research, there are over 27 thousand sites across America offering testing and treatment."
Answered by AI
What medical conditions can be treated with CAR T cell therapy?
"CAR T cells are indicated for certain types of lymphoma, leukemia, retinoblastoma and other myelocytic diseases - including multiple sclerosis."
Answered by AI
To what extent could CAR T cells prove to be harmful for individuals?
"CAR T cells have only been tested in limited clinical studies, so their safety and efficacy rating on our scale is 1."
Answered by AI
Are there still opportunities for patient enrollment in this experiment?
"Correct. Clinicaltrials.gov shows that this trial, which was initially posted on September 30th 2020 and last updated October 10th 2022, is no longer enrolling patients. Fortunately, 968 other studies are in search of participants at the moment."
Answered by AI
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