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Engineered T Cell Therapy for Cancer
Study Summary
This trial will test if a new cancer treatment is safe and effective.
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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- My lung cancer has spread to my brain, but I may still qualify based on specific conditions.I have a history of or currently have a demyelinating disease.I have non-small cell lung cancer.My cancer is advanced, cannot be surgically removed, and has a specific genetic feature.I have the HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 gene.I have not had major surgery in the last 4 weeks.I am 18 or older and weigh at least 40 kg.I have a severe autoimmune disease treated with steroids or immunosuppressants in the last year.My tumor is positive for NY-ESO-1 or LAGE-1a.I've had standard cancer treatment, including anthracycline or ifosfamide, unless I couldn't tolerate them.I have tried or cannot tolerate specific cancer treatments as per guidelines.I have followed the required break period after my last cancer treatment.My lung cancer is at stage IV, confirmed by tests.You have received a stem cell or organ transplant within the past 5 years.I have had gene therapy with an integrating vector before.I am fully active or can carry out light work.My organs are working well and my blood cell counts are healthy.I have another cancer that is not fully in remission.I'm sorry, but without knowing what "SS/ MRCLS" stands for, I am unable to provide a simplified explanation of the additional criteria. Could you please provide more information or clarify the abbreviation?I have a serious illness affecting my whole body.I have been treated with NY-ESO-1 specific therapies before.
- Group 1: Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS
- Group 2: Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC
- Group 3: Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS
- Group 4: Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS
- 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 risks does GSK3901961 pose to human health?
"Based on the level of safety and efficacy data available, GSK3901961 was given a score of 1. This is due to it being currently in Phase 1 trials."
What goals is this trial hoping to accomplish?
"The primary objective of this trial, measured over a four year period, is to evaluate the frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI). Secondary objectives encompass duration of response in those who demonstrate complete or partial remission, phenotype analysis on transduced T cells, and time taken for maximum concentration."
How many people are being accepted into this scientific experiment?
"Affirmative. According to evidence hosted on clinicaltrials.gov, this experiment is actively searching for participants and was first posted in December 2020 with an update made in August 2022. The study requires 67 volunteers evenly distributed across 12 different sites."
Are there any recruitment opportunities available for this trial currently?
"Affirmative. The information hosted on clinicaltrials.gov attests that this medical trial is now recruiting participants and was first published in December 2020. As of August 2022, 67 patients must be enrolled across 12 different sites to take part in the study."
Would you be able to provide details on prior investigations involving GSK3901961?
"GSK3901961 was initially trialed in 1997 at City of Hope Comprehensive Cancer Center. Now, there are a total of 1275 completed studies and 889 ongoing trials--particularly prominent in Montreal, Quebec."
For what medical issues is GSK3901961 usually prescribed?
"GSK3901961 is chiefly deployed to control the progression of multiple sclerosis, but it has also demonstrated efficacy in treating mixed-cell type lymphoma, leukemia, myelocytic acute retinoblastoma."
How many healthcare facilities have been selected to conduct this experiment?
"The current medical trial is accepting participants from 12 different sites, including Montreal, Saint Louis and Lexington. To reduce the need for travel during this study, it is suggested that you select a clinic in close proximity to your location."
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