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Genetically Engineered T Cells + Chemotherapy for Ovarian Cancer
Study Summary
This trial is testing T cells that have been genetically engineered to target and kill cancer cells, given after a chemotherapy regimen designed to make room in the bone marrow for new blood cells. The hope is that this will replace the immune system with new cells that are better able to attack and kill cancer cells.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have active brain metastases, unless they have been successfully treated with surgery or radiation and are under control.You have had allergic reactions to similar medications in the past.You have taken certain medications like corticosteroids or immunomodulating agents within the last 30 days.You are able to perform daily activities without difficulty or with a little difficulty.You need to have a specific genetic marker called HLA-A*02.1 and HLA-DP*04. If you have already been tested positive for these markers before, you don't need to be tested again.You have had a heart attack in the past 6 months, serious heart rhythm problems, or severe congestive heart failure. If needed, a heart stress test will be done by the study doctor.You have a specific type of ovarian, peritoneal, or fallopian tube cancer that has come back after treatment, and you have already tried at least one standard treatment for this type of cancer.You are expected to live for more than 4 months.Your platelet count is at least 100 billion per liter.Your tumor must test positive for NY-ESO-1 using a specific type of test.You have an ongoing infection with HIV, hepatitis B, hepatitis C, or cytomegalovirus.You are not able to come in for check-up appointments.You had another type of cancer, except for non-melanoma skin cancer, within the past 3 years.Your white blood cell count is equal to or greater than 3 billion per liter.You have breathing test results that show abnormalities.Your disease must be able to be measured using specific guidelines.Your white blood cell count is at least 1.5 billion per liter.Your bilirubin levels are within the normal range for the hospital or clinic where you are being treated.Your AST and ALT levels in the blood are not more than 2.5 times the normal limit for the testing facility.Your creatinine level should be within a certain range, and if it's higher, your kidneys need to work well.
- Group 1: Treatment (autologous NY-ESO-1 engineered T and HSC)
- 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
What is the total enrollment of participants for this medical trial?
"This current trial is not currently seeking new participants at this time. The posting date was March 8th, 2019 and it has most recently been updated on July 13th 2022. For those looking for other clinical trials, there are 3914 studies recruiting patients with ovarian cancer and an additional 89 investigations admitting individuals for Autologous NY-ESO-1-specific CD8-positive T Lymphocyte treatments."
Could you outline the prior research undertaken related to Autologous NY-ESO-1-specific CD8-positive T Lymphocytes?
"At the moment, 89 trials are in progress to research Autologous NY-ESO-1-specific CD8-positive T Lymphocytes. 7 of those studies have entered Phase 3 development and there is representation across 1281 sites worldwide; with Boston, Massachusetts hosting most of them."
Are researchers currently accepting participants for this clinical trial?
"This research project has gone past the recruitment phase. It was first advertised on March 8th, 2019 and its last edit was on July 13th 2022. If you are still looking to take part in a clinical trial, there are 3914 trials enlisting participants with ovarian cancer as well as 89 studies recruiting for Autologous NY-ESO-1-specific CD8-positive T Lymphocytes."
What are Autologous NY-ESO-1-specific CD8-positive T Lymphocytes most frequently utilized for?
"Autologous NY-ESO-1-specific CD8-positive T Lymphocytes is often used to treat malignant effusion, as well as various other illnesses such as mycosis fungoides (MF) and chronic lymphocytic leukemia (CLL). Additionally, it can aid patients with Stage I Mycosis Fungoides."
Has Autologous NY-ESO-1-specific CD8-positive T Lymphocytes been granted authorization by the FDA?
"Autologous NY-ESO-1-specific CD8-positive T Lymphocytes scored a 1 on our safety scale since this is an early Phase 1 trial, with limited evidence of its efficacy and safety."
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