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Armored CAR T-Cell Therapy for Pediatric Solid Cancers
Study Summary
This trial is for people with cancer that has returned or has not gone away after standard treatment, and/or for people who cannot receive standard treatment.
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 liver is functioning well enough for treatment.I can care for myself but may need occasional help.My tumor is GPC3-positive and has relapsed or is not responding to treatment.You are expected to live for at least 16 more weeks.I am between 1 and 21 years old.You are expected to live for at least 12 more weeks.Your Child-Pugh-Turcotte score is 7 or higher.My liver cancer is at an early to intermediate stage.I can care for myself but may need occasional help.I am not on high doses of steroids or can stop them 24 hours before CAR T cell therapy.I do not have any infections that aren't responding to treatment.I am between 1 and 21 years old.You have been diagnosed with HIV.I have had an organ transplant.I am allergic to mouse protein products or have human anti-mouse antibodies.I do not have any active infections, except possibly Hepatitis B or C.My liver cancer is at an early to intermediate stage.
- Group 1: CARE T cells + Fludarabine and Cytoxan
- 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 the FDA sanctioned any CARE T cell treatments?
"CARE T cells, which are currently undergoing testing in a phase 1 clinical trial and have only limited evidence of safety and efficacy, were given an initial score of 1."
What is the current enrollment size for this medical experiment?
"As of now, this clinical trial is not enrolling participants. It was originally posted on July 3rd 2023 and last revised on December 1st 2021. For those interested in participating in medical studies, there are currently 2538 trials for Wilms Tumor recruiting patients, as well as 889 studies relating to CAR-T cells which require volunteers."
What credentials must a participant possess to take part in this research?
"This trial is seeking 24 children between 1 year and 21 years of age who are currently diagnosed with Wilms tumour. Additionally, participants need to meet the following criteria: a Lansky/Karnofsky performance score of 60% or higher; completion & signing of an informed consent form given by the patient/guardian; eligibility for procurement; relapse or refractory GPC3-positive* solid tumors (as determined by immunohistochemistry); life expectancy longer than 16 weeks; Barcelona Clinic Liver cancer Stage A, B or C (for patients with hepatocellular carcinoma only); Child-Pugh-Turc"
What medical conditions can be addressed with CARE T cell treatments?
"Several maladies, including multiple sclerosis, mixed-cell type lymphoma and acute myelocytic leukemia can be remedied with CARE T cells."
Are recruitment efforts still underway for this research project?
"This clinical trial is not currently accepting new enrollees, as per the information recorded on clinicaltrials.gov. While this study was initially posted in July of 2023 and most recently updated in December 2021, there are 3,427 other trials actively searching for participants at present."
Has there been any prior experimentation involving CARE T cells in a clinical setting?
"Presently, there are 889 ongoing medical studies assessing CARE T cells with 161 trials at Phase 3. Philadelphia holds numerous of the examinations for CARE T cells, but 28443 locations across the nation have active experiments involving this cellular therapy."
Does this investigation include participants aged fifty or above?
"This clinical trial has a minimum participation age of 1 year old and a maximum age limit of 21 years."
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