IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Comprehensive Cancer Center, Duarte, CAMelanoma+4 MoreIL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Metastatic Melanoma
  • Cutaneous Melanoma Stage III
  • Asthma-COPD Overlap Syndrome (ACOS)
  • Stage IV Cutaneous Melanoma

Treatment Effectiveness

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Up 2 years

Year 2
Complete response
Partial response
Day 1
IL13Ralpha2 CAR T cell persistence
Year 2
Overall survival
Up 2 years
Cytokine release syndrome analysis
Evaluation of an endogenous T cell anti-tumor response
IL13Ralpha2 CAR T Cell phenotypic monitoring
Impact of IL-2 on systemic persistence of CAR T cells
Impact of IL-2 on tumor infiltration of CAR T cells
Up to 120 days
Objective response rate
Up to 2 years
Response for in-transit metastasis
Time to disease progression
Day 90
Dose-limiting toxicity (DLT)
Incidence of adverse events

Trial Safety

Trial Design

1 Treatment Group

Treatment (chemotherapy, IL13Ralpha2, Il-2)
1 of 1

Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells · No Placebo Group · Phase 1

Treatment (chemotherapy, IL13Ralpha2, Il-2)Experimental Group · 4 Interventions: IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells, Cyclophosphamide, Fludarabine Phosphate, Recombinant Interleukin-2 · Intervention Types: Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up 2 years

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
341 Previous Clinical Trials
21,536 Total Patients Enrolled
18 Trials studying Melanoma
459 Patients Enrolled for Melanoma
City of Hope National Medical CenterOTHER
15 Previous Clinical Trials
3,871 Total Patients Enrolled
Anusha KalbasiPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
14 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced melanoma and have already received one type of treatment such as anti-PD-1 therapy or a combination of BRAF and MEK inhibitors. Your doctor has determined that there are no other options for a cure.

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.