Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma

Breast Cancer Clinical Trial

Official title: Phase 1 Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma

Status Recruiting

Clinical Trial 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. 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 patients 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.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Safety. SECONDARY OBJECTIVES: I. Clinical response. II. Chimeric antigen receptor (CAR) T-cell tumor infiltration and persistence. III. Impact of IL-2 on the persistence and tumor infiltration of IL13Ralpha2 CAR T cells. EXPLORATORY OBJECTIVES: I. Cytokine release syndrome analysis. II. Evaluation of endogenous anti-tumor immune response. OUTLINE: This is a dose-escalation study of IL13Ralpha2-specific hinge-optimized 4-1BB-co-stimulatory CAR/truncated (Cluster of Differentiation 19) CD19-expressing autologous TN/MEM cells (IL13Ralpha2 CAR T cells). Patients receive cyclophosphamide intravenously (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 cells IV on day 0. Patients may also receive recombinant interleukin-2 subcutaneously (SC) twice daily (BID) on days 1-7. After completion of study treatment, patients are followed every 2-3 months for 2 years, every 6 months for 3 years, then every year for at least 15 years. ;

Related Conditions & MeSH terms

• Acral Melanoma
• Adenocarcinoma of Lung
• Adrenocortical Carcinoma
• Breast Cancer
• Carcinoma
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Cutaneous Melanoma, Stage III
• Cutaneous Melanoma, Stage IV
• Head and Neck Squamous Cell Carcinoma
• IL13RA2 Positive
• Lung Adenocarcinoma
• Melanoma
• Metastatic Melanoma
• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor
• Paraganglioma
• Skin Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Thyroid Cancer
• Uveal Melanoma

• NCT number: NCT04119024
• Study type: Interventional
• Source: Jonsson Comprehensive Cancer Center
• Contact: Jacob Naparstek
• Phone: 310-206-9926
• Email: JNaparstek@mednet.ucla.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: November 27, 2019
• Completion date: October 1, 2025