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Gene-Modified T Cells for Advanced Cancers
Study Summary
This trial is testing the side effects and best dose of gene-modified T cells, given with or without decitabine, to treat patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have had a serious autoimmune disease or inflammatory bowel disease in the past.I am currently taking steroids or drugs that affect my immune system.My cancer is inoperable or has spread and falls into one of the specified categories.My treatment history matches the specific requirements for my type of cancer.Patients must have specific-sized areas of disease that can be measured.I do not have any unmanaged ongoing illnesses.I currently have an active infection.I can provide a tissue sample for NY-ESO-1 testing or am willing to have a biopsy.I am eligible for a second transgenic T cell infusion.My veins are suitable for apheresis.I have active brain tumors.I do not have dementia or significant changes in my mental status.
- Group 1: Cohort I (cyclophosphamide, TCR/dnTGFbetaRII)
- Group 2: Cohort II (decitabine, cyclophosphamide, TCR/dnTGFbetaRII)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Have there been any other explorations into the effects of TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes?
"Currently, there are 909 clinical trials examining the efficacy of TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes. Of those studies, 165 have reached phase 3 and 29294 sites across America are conducting research related to this treatment. The majority of these experiments take place in Philadelphia, Pennsylvania."
Is it still possible for individuals to seek inclusion in this trial?
"This investigation is no longer inviting participants; the trial was first published on July 14th 2017 and last updated on May 31st 2022. For those hoping to join another medical study, 4035 studies are currently enrolling patients with malignant neoplasm of ovary and 909 clinical trials are accepting candidates for TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes."
To what maladies does TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes typically provide relief?
"Multiple sclerosis is often remedied through the use of Transforming Growth Factor Beta-Dependent Negative Regulator II (TGFbDNRII)-transduced Autologous Tumor Infiltrating Lymphocytes. Besides MS, this treatment has been proven beneficial for a variety of other ailments such as leukemia, myelocytic, acute and retinoblastoma, in addition to histiocytic lymphoma."
What is the overall participant count for this medical experiment?
"At the present moment, this research study is not enrolling any new participants. The trial was opened on July 14th 2017 and last amended on May 31st 2022; if you are looking for alternatives, there are 4035 clinical trials currently accepting patients with malignant neoplasms of ovary and 909 studies recruiting TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes."
What is the anticipated outcome of this experiment?
"The primary purpose of this clinical trial is to evaluate the manufacturability of NY-ESO-1/ dnTGFbetaRII engineered cells over a period of approximately one month. Secondary endpoints are tumor response (complete and partial) measured through Response Evaluation Criteria in Solid Tumors (RECIST 1.1), expression levels of NY-ESO-1 transgenic protein present in peripheral blood mononuclear cells at various points during the study, as well as an assessment done every 3 months for the first year and then every 6 to 12 months thereafter."
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