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CAR T-cell Therapy

IL13Ralpha2 CAR T Cells for Advanced Skin Cancer

Phase 1
Recruiting
Led By Anusha Kalbasi
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
Creatinine < 2 mg/dL (or a glomerular filtration rate > 45) (determined within 30?60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up 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 below
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My kidney function is within the required range for the study.
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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 weeks
Treatment ~ Varies
Follow Up ~up 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up 2 years for reporting.

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 (DLT)
Incidence of adverse events
Secondary outcome measures
Complete response
IL13Ralpha2 CAR T Cell phenotypic monitoring
IL13Ralpha2 CAR T cell persistence
+7 more
Other 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, Il-2)Experimental Treatment4 Interventions
Patients receive cyclophosphamide IV over 1 hour on days -5 to -4 and fludarabine phosphate IV over 15-30 minutes on days -4 to -1. Patients then receive IL13Ralpha2 CAR T cell IV on day 0. Patients may also receive recombinant interleukin-2 SC BID on days 1-7.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine Phosphate
1997
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

City of Hope National Medical CenterOTHER
15 Previous Clinical Trials
3,857 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,058 Total Patients Enrolled
19 Trials studying Melanoma
609 Patients Enrolled for Melanoma
Anusha KalbasiPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
14 Total Patients Enrolled

Media Library

IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04119024 — Phase 1
Melanoma Research Study Groups: Treatment (chemotherapy, IL13Ralpha2, Il-2)
Melanoma Clinical Trial 2023: IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells Highlights & Side Effects. Trial Name: NCT04119024 — Phase 1
IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04119024 — Phase 1

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
~2 spots leftby Oct 2024