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ADP-A2M4CD8 + Immunotherapy for Advanced Cancers
Study Summary
This trial will study ADP-A2M4CD8 T-cell therapy, given to people with certain HLA types and tumors that express the MAGE-A4 antigen. Tumor types include endometrial, esophageal, EGJ, gastric, head and neck, melanoma, NSCLC, ovarian, and urothelial cancer.
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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- The pumping function of your heart is at least 50% or within the normal range set by the hospital.I have at least one HLA-A*02 gene variant.I am fully active or can carry out light work.My tumor tests positive for MAGE-A4.My cancer can be measured by scans before specific treatments.You have had allergic reactions to drugs similar to fludarabine or cyclophosphamide in the past.I have a serious heart condition.I am between 18 and 75 years old.I have another cancer that is not fully in remission.I do not have an active infection with HIV, hepatitis B, hepatitis C, or HTLV.Your oxygen levels while resting are at least 90% when breathing normal air.I have been diagnosed with a specific type of cancer such as lung, ovarian, or skin cancer.I do not have cancer spread to the brain or spinal cord that is causing symptoms.You have a disease that affects your immune system and is currently active.My genetic test shows I have a specific HLA-A*02 allele.I do not have any unmanaged ongoing illnesses.
- 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
Does this research endeavor include persons aged eighty or above?
"Patients aged 18 to 75 are eligible for enrollment in this medical research."
What criteria must be fulfilled to qualify for this medical experiment?
"This clinical trial is seeking 90 adults, between 18 and 75 years old, with a melanoma diagnosis. Furthermore, to be eligible for the trial they must meet additional criteria such as having at least one HLA-A*02 inclusion allele present in their system, measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion., MAGE-A4 expression confirmed by central laboratory testing, LVEF ≥50% or institutional lower limit of normal range (whichever is lower), and ECOG Performance Status of 0 or 1."
How many venues are carrying out the research project?
"The 12 sites participating in the trial are comprised of The University of Oklahoma Health Sciences Center (Oklahoma City), Massachusetts General Hospital (Boston) and OU Health Stephenson Cancer Centre (Houston). Additionally, there are 9 other medical centres running this study."
Are there vacancies in this clinical trial for participation?
"According to the information posted on clinicaltrials.gov, this medical trial is still open for recruitment. The study was first uploaded in August 20th 2019 and its details were most recently updated three years later."
Is there any risk associated with Autologous genetically modified ADP-A2M4CD8 cell treatment?
"Our team assessed the safety of Autologous genetically modified ADP-A2M4CD8 cells to be a 1 due to it being in Phase 1. Thus, there is limited evidence for its efficacy and safety."
What is the aggregate tally of participants in this clinical experiment?
"A total of 90 eligible participants are needed to commence this clinical trial. Recruited patients can be found at the University of Oklahoma Health Sciences Center (Oklahoma City, OK) and Massachusetts General Hospital (Boston, MA)."
What aims is this clinical trial attempting to achieve?
"This trial seeks to evaluate the number of patients experiencing treatment-related adverse events, including serious adverse reactions, over two and a half years. The secondary goals include assessing duration of stable disease, anti-tumour activity via overall response rate, and time taken to achieve a partial or complete response."
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