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Gene Transfer Therapy for Gastrointestinal Cancer
Study Summary
This trial is testing a new cancer therapy that involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. The therapy is called gene transfer using anti-KRAS G12V mTCR cells.
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?
Media Library
- I have received extensive radiation therapy to my lungs.My cancer is advanced, cannot be surgically removed, and has a specific genetic mutation.I do not have any current infections.I do not have any active infections, bleeding disorders, or serious illnesses.I am currently taking steroid medication.I have had heart surgery or symptoms due to poor blood flow.My heart and lung functions are within safe limits.I am HLA-A*11:01 positive as confirmed by testing.My advanced cancer did not respond to or has returned after standard treatment.I am between 18 and 72 years old.My chemotherapy is tailored to my cancer type or due to medication allergies.I have up to 3 small brain tumors that don't cause symptoms.I am fully active or can carry out light work.I will take a pregnancy test before starting treatment.I am currently pregnant or breastfeeding.
- Group 1: 1/Phase I
- Group 2: 2/Phase II
- 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 medical conditions has Anti-KRAS G12V mTCR PBL been found to alleviate?
"Multiple sclerosis, Leukemia, Myelocytic Acute, and Retinoblastoma have all been identified as potential targets for Anti-KRAS G12V mTCR PBL."
Are there documented precedents of Anti-KRAS G12V mTCR PBL clinical trials?
"At present, there are 163 Phase 3 trials and 913 overall studies on Anti-KRAS G12V mTCR PBL. These experiments have been set up in a total of 28673 different areas with the majority being conducted in Philadelphia, Pennsylvania."
Are the parameters for participant eligibility restricted to those under 25 years of age?
"Potential participants for this trial must be aged 18 and above, but not yet 70."
Is this experiment actively seeking volunteers?
"As per the data on clinicaltrials.gov, this investigation is currently recruiting volunteers. It was initially posted in September 2017 and most recently edited in October 2022."
Do I satisfy the criteria to partake in this research?
"This medical study is looking for 110 individuals, aged 18 to 70 years old, who have been diagnosed with malignant neoplasm of the colon. To be eligible, participants must additionally comply with a range of conditions that include: being HLA-A*11:01 positive as verified by an NIH Transfusion Medicine lab; confirmation of their cancer diagnosis by NCI Laboratory Pathology and having measurable metastatic unresectable tumours expressing G12V mutated KRAS (as established through RT-PCR on tumor tissue); having had at least two rounds of systemic chemotherapy containing 5FU, leucovorin plus bev"
What is the headcount of participants in this experiment?
"Affirmative. Clinicaltrials.gov reports that this clinical trial, which was first shared on September 21st 2017, is still actively seeking participants. 110 individuals are necessary to be enrolled from 1 hospital site."
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