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Afamitresgene Autoleucel for Sarcoma
Study Summary
This trial is studying a new treatment for synovial sarcoma and MRCLS.
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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- I am between 16 and 75 years old, or between 10 and 75 at certain locations.I have been treated with anthracycline or ifosfamide before.I am HLA-A*02 positive.I have brain metastases causing symptoms.I have been diagnosed with advanced synovial sarcoma or myxoid liposarcoma, confirmed by genetic testing.I do not have any unmanaged ongoing illnesses.You have a history of a disease where your immune system attacks your own body.I am fully active or can carry out light work.My tumor tests positive for MAGE-A4.You have had allergic reactions to similar drugs like fludarabine or cyclophosphamide in the past.I do not have an active infection with HIV, hepatitis B, hepatitis C, or HTLV.I have another cancer that is not fully in remission.I have the HLA-A*02:05 gene.I have a serious heart condition.I am between 10 and 16 years old and can do most activities without help.
- Group 1: Autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) SPEAR™ T 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
Has afamitresgene autoleucel (previously ADP-A2M4) received FDA approval?
"Afamitresgene autoleucel (previously ADP-A2M4) is currently in Phase 2 of clinical trials. While there is evidence suggesting that it is safe, there is no data yet to support its efficacy."
Where are patients able to enroll in this trial?
"There are presently 19 sites where this clinical trial is enrolling patients. The locations in Toronto, Columbus and New york as well as the other 16 locations. To help reduce participant burden, it is advisable to choose the location nearest you."
How many people are currently enrolled in this clinical trial?
"The listing on clinicaltrials.gov verifies that this research is still open to new patients. The study was established on 8/13/2019, with the most recent update occurring on 10/5/2022. They are looking for 90 individuals total, which will be drawn from 19 different locations."
Does this research project restrict volunteers to those under 25 years old?
"The aim of this clinical study is to recruit patients who are over the age of 10 and under the age of 75."
Can new patients still sign up for this program?
"The study, which was originally published on August 13th 2019 and last updated October 5th 2020, is still recruiting patients."
How can I sign up to participate in this research?
"This study is investigating a potential treatment for synovial sarcoma and thus patients with this diagnosis are encouraged to apply. The age limit for participants is between 10 and 75 years old, and the team leading the trial hopes to have around 90 people enrolled by the end."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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