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ADP-A2M4CD8 T-Cell Therapy for Esophageal Cancer
Study Summary
This trial will test if a new cancer treatment, ADP-A2M4CD8 T-cell therapy, is effective against esophageal and EGJ cancer expressing the MAGE-A4 protein.
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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 a serious medical condition that is not well-managed.You have already received treatment for advanced or spreading disease.Please note that there may be additional requirements you must meet to participate in the study, which will be explained in the study's official guidelines.You are pregnant or currently breastfeeding.You have had cancer before that is not considered fully treated, or you have a heart condition that can affect your health.Please keep in mind there may be additional rules to determine if you can participate in the study.You have had allergic reactions to drugs similar to fludarabine or cyclophosphamide used in the study.You currently have an autoimmune or immune-mediated disease that is not under control.
- Group 1: Autologous genetically modified ADP-A2M4CD8 cells
- 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
Are there any safety risks associated with Autologous genetically modified ADP-A2M4CD8 cells use?
"Our team at Power has rated Autologous genetically modified ADP-A2M4CD8 cells as a 2 on the safety scale, since there is evidence of its security but no proof that it can be effective."
Does this research project allow participants aged sixty or older to take part?
"The parameters state that only individuals aged between 18 and 75 are eligible to be part of this trial. There is a separate set of 10 trials available for those below the age of majority, as well as 378 distinct studies tailored towards seniors over 65 years old."
Is there presently an opportunity for individuals to join this research project?
"The information on clinicaltrials.gov reveals that this trial is still actively seeking participants and has been since September 15th 2021. It was most recently updated on August 23rd 2022."
Is it possible for me to join this research project?
"This clinical trial is recruiting 45 persons with esophageal cancer under the age of 75 and over 18. Eligibility for this study includes HLA-A*02 positivity, MAGE-A4 expression as determined by a central laboratory, RECIST v1.1 measurable disease criteria, ECOG Performance Status 0 or 1, and LVEF ≥50%. Other protocol specific qualifications may also be applicable."
What is the size of the sample group for this research?
"To adequately assess the efficacy of this medical intervention, 45 suitable candidates are required for enrolment. These patients will be accepted from Froedtert Hospital and Medical College of Wisconsin in Milwaukee, Wisconsin or Providence Cancer Institute Franz Clinic in Portland, Oregon."
Can you enumerate the amount of locations participating in this research within the city?
"The present clinical trial is being administered in 25 different hospitals, including Milwaukee, Portland and Toronto. Participants should select the site closest to them for minimal travel requirements."
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