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CAR T-cell Therapy
IL13Ralpha2 CAR T Cells for Advanced Skin Cancer
Phase 1
Recruiting
Led By Antoni Ribas
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have received at least one prior systemic therapy for advanced melanoma (i.e. anti-PD-1 therapy, BRAF plus MEK inhibitor therapy for BRAFV600 mutated melanoma) and is not considered to have an alternate treatment option with curative intent
A minimum of one measurable lesion defined as meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) or skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from study enrollment to the date of progressive disease first documented disease progression per recist v1.1 or death due to any cause by investigator assessment, whichever occurs first, assessed up to 2 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced melanoma (Stage IIIC or IV) who have tried at least one other treatment and can't be cured by surgery. They must have a certain protein on their cancer cells, be in good physical shape, and able to undergo a procedure to collect immune cells. Pregnant women, those with heart issues, severe allergies to study drugs, active infections like HIV or hepatitis B/C, or using immunosuppressive drugs can't join.Check my eligibility
What is being tested?
The trial tests genetically modified immune cells called IL13Ralpha2 CAR T Cells after chemotherapy (cyclophosphamide and fludarabine phosphate) plus interleukin-2. It aims to find the safest dose of these modified cells that stay in the body and effectively target melanoma.See study design
What are the potential side effects?
Possible side effects include reactions from the infusion of modified T-cells, effects from chemotherapy such as nausea and hair loss, increased risk of infection due to weakened immunity from conditioning treatments, fatigue, fever, and potential organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had treatment for advanced melanoma but no curative options are left.
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I have at least one tumor that can be measured accurately.
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My tumor shows IL13Ralpha2 expression.
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I am fully active or can carry out light work.
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My melanoma cannot be removed by surgery and is either stage IIIC or IV.
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I am willing to undergo a procedure to collect white blood cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from study enrollment to the date of progressive disease first documented disease progression per recist v1.1 or death due to any cause by investigator assessment, whichever occurs first, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from study enrollment to the date of progressive disease first documented disease progression per recist v1.1 or death due to any cause by investigator assessment, whichever occurs first, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity
Incidence of adverse events
Secondary outcome measures
Complete response (CR)
Duration of overall complete response
Duration of overall response
+8 moreOther outcome measures
Cytokine release syndrome analysis
Evaluation of an endogenous T cell anti-tumor response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, IL13Ralpha2)Experimental Treatment9 Interventions
Patients may receive cyclophosphamide IV over 60 minutes on days -5 to -3 and fludarabine phosphate IV over 15-30 minutes on days -5 to -2. Patients then receive IL13Ralpha2 CAR T cells IV on day 0. Patients also undergo biopsy at baseline and on study, CT, or PET and CT scan at screening and on study, magnetic resonance imaging (MRI) throughout the trial, and collection of blood samples throughout the trial. Patients with disease progression may receive a second cycle with an infusion of IL13Ralpha2 CAR T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2210
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
Melanoma Research AllianceOTHER
8 Previous Clinical Trials
526 Total Patients Enrolled
8 Trials studying Melanoma
526 Patients Enrolled for Melanoma
Parker Institute for Cancer ImmunotherapyOTHER
10 Previous Clinical Trials
440 Total Patients Enrolled
3 Trials studying Melanoma
37 Patients Enrolled for Melanoma
California Institute for Regenerative Medicine (CIRM)OTHER
65 Previous Clinical Trials
3,159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (chemotherapy, IL13Ralpha2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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