RecruitingPhase 1NCT04119024

Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors

Phase I Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors


Sponsor

Anusha Kalbasi

Enrollment

18 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and best dose of modified immune cells (IL13Ralpha2 CAR T cells) after a chemotherapy conditioning regimen for the treatment of patients with stage IIIC or IV melanoma or solid tumors that have spread to other places in the body (metastatic). The study agent is called IL13Ralpha2 CAR T cells. T cells are a special type of white blood cell (immune cells) that have the ability to kill tumor cells. The T cells are obtained from the patient's own blood, grown in a laboratory, and modified by adding the IL13Ralpha2 CAR gene. The IL13Ralpha2 CAR gene is inserted into T cells with a virus called a lentivirus. The lentivirus allows cells to make the IL13Ralpha2 CAR protein. This CAR has been designed to bind to a protein on the surface of tumor cells called IL13Ralpha2. This study is being done to determine the dose at which the gene-modified immune cells are safe, how long the cells stay in the body, and if the cells are able to attack the cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cutting-edge treatment where immune cells from a patient's own body are genetically modified in the lab and then given back to fight advanced melanoma or other solid tumours that have not responded to other treatments. The cells are engineered to target a protein called IL13Ralpha2 found on cancer cells. **You may be eligible if...** - You are between 18 and 74 years old - You have stage IIIC or IV melanoma (including brain metastases) or another metastatic solid tumour that has not responded to all available standard treatments - Your tumour tests positive for the IL13Ralpha2 protein - You are in good physical condition (ECOG 0 or 1) - Your blood counts meet required minimums **You may NOT be eligible if...** - Your tumour does not express the IL13Ralpha2 protein - Your cancer has spread to the central nervous system (for non-melanoma cancers) - You are 75 years old or older - Your performance status or blood counts are below required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo CT scan

DRUGCyclophosphamide

Given IV

DRUGFludarabine Phosphate

Given IV

OTHERFludeoxyglucose F-18

Undergo FDG-PET/CT scan

BIOLOGICALIL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET scan


Locations(3)

City of Hope

Duarte, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Stanford Cancer Institute

Stanford, California, United States

View Full Details on ClinicalTrials.gov

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NCT04119024


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