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IL13Ralpha2 CAR T Cells for Advanced Skin Cancer
Study Summary
This trial is studying the side effects and best dose of genetically modified immune cells, called IL13Ralpha2 CAR T cells, for patients with stage IIIC or IV melanoma.
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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- My kidney function is within the required range for the study.You have advanced melanoma that cannot be cured with surgery, and your tumor shows a certain protein when tested. Also, your overall physical condition is good.Your absolute neutrophil count is at least 1 x 10^9 cells/L, as checked within 30-60 days before starting the trial, and re-checked within 14 days of starting chemotherapy.My lung function is below 70% of what is expected.I may need or have recently taken systemic steroids, but not inhaled or topical ones.I have heart issues with a heart pump function less than 45%.You have HIV or other immune system disorders that could make it risky for you to have chemotherapy. If you have an infectious disease that wasn't known before, you will be referred to your regular doctor or an infectious disease specialist.You have severe memory or thinking problems that would make it hard for you to understand and follow the study rules.My heart test results are normal or cleared by a cardiologist.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use effective birth control.I do not have another active cancer that could affect this study's results.You have hepatitis B or C with signs of ongoing liver damage that could make the treatment risky for your liver. If you are found to have hepatitis during the testing and didn't know it before, you will be sent to a doctor who specializes in infectious diseases.I've had treatment for advanced melanoma but no curative options are left.Unable to collect at least 10 million T cells from the blood.I have at least one tumor that can be measured accurately.Your liver enzymes (AST, ALT) are not more than 2.5 times the upper limit of normal, as determined by a recent blood test.You have had a bad reaction to any of the drugs used in this study, or you are sensitive to cyclophosphamide or fludarabine.Your platelet count is at least 75 x 10^9/L, and this was checked within the last 30-60 days before joining the study. It will be checked again within 14 days of starting chemotherapy.Your hemoglobin level is at least 8 grams per deciliter, as checked within the past 30-60 days before joining the trial, and will be rechecked within 14 days of starting chemotherapy.I haven't had any cancer treatments, including immunotherapy, in the last 14 days.My tumor shows IL13Ralpha2 expression.I am fully active or can carry out light work.My melanoma cannot be removed by surgery and is either stage IIIC or IV.I am willing to undergo a procedure to collect white blood cells.Your total bilirubin level should be no higher than twice the upper limit of normal, unless you have Gilbert's syndrome.
- Group 1: Treatment (chemotherapy, IL13Ralpha2, Il-2)
- 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
Is the FDA permitting any clinical application of IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19 Autologous TN/MEM Cells?
"Our team at Power has assessed the safety of IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19 Expressing Autologous TN/MEM Cells to be a 1 due to its status as a Phase 1 study, indicating that there is limited information on both efficacy and safety."
What health issue can be managed with the aid of IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells?
"IL13Ralpha2-specific Hinge-optimized 4-1BB co-stimulatory CAR/Truncated CD19 expressing Autologous TN/MEM Cells are primarily used to manage multiple sclerosis. This therapy can also potentially help patients with leukemia, myelocytic, acute and retinoblastoma histiocytic lymphomas."
What findings have past researchers discovered when utilizing IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19 Autologous TN/MEM Cells?
"Currently, there are 901 clinical trials for IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells with 161 of them in Phase 3. Philadelphia, Pennsylvania has a large number of those studies running within its borders but globally the total is 28476 locations."
What is the cohort size of this particular research endeavor?
"Affirmative, the information provided on clinicaltrials.gov indicates that this research is in its active recruitment phase and began accepting applications as of November 27th 2019. The study seeks 24 participants from two separate trial sites."
Are investigators still enrolling for this research endeavor?
"Affirmative. According to the information hosted on clinicaltrials.gov, this research study is currently looking for volunteers; it was initially posted in November 2019 and modified a few days ago in April 2022. The team is recruiting 24 individuals from two different facilities."
Who else is applying?
What portion of applicants met pre-screening criteria?
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