OncoMatch/Clinical Trials/NCT04119024
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
Is NCT04119024 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells and Cyclophosphamide for metastatic malignant solid neoplasm.
Treatment: Cyclophosphamide · Fludarabine Phosphate · IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Melanoma
Neuroendocrine Tumor
Thyroid Cancer
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: IL13RA2 expression (IHA H-Score >= 50 in at least 10% of the total tumor specimen and in at least two high-power fields)
Confirmed IL13Ralpha2 tumor expression by immunohistochemistry (immunohistochemical assay [IHA] H-Score >= 50 in at least 10% of the total tumor specimen and in at least two high-power fields)
Disease stage
Required: Stage IIIC, IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor — melanoma
Patients with melanoma must have progressed following >= 1 line of systemic therapy, including immune checkpoint inhibitor and a BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation
Must have received: BRAF inhibitor — melanoma with BRAF V600-activating mutation
BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation
Must have received: MEK inhibitor — melanoma with BRAF V600-activating mutation
BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation
Cannot have received: systemic cancer therapy
Exception: within 14 days prior to initiation of conditioning chemotherapy
Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol
Lab requirements
Blood counts
ANC >= 1 x 10^9 cells/L; platelets >= 75 x 10^9/L; hemoglobin >= 9.5 g/dL
Kidney function
Creatinine < 2 mg/dL (or a glomerular filtration rate > 45)
Liver function
AST, ALT <= 2.5 x ULN; total bilirubin <= 2 x ULN (except patients with documented Gilbert's syndrome)
Cardiac function
LVEF >= 45% on cardiac stress test; no clinically significant ECG abnormalities, symptoms of cardiac ischemia or arrhythmias
Absolute neutrophil count (ANC) >= 1 x 10^9 cells/L; Platelets >= 75 x 10^9/L; Hemoglobin >= 9.5 g/dL; AST, ALT <= 2.5 x ULN; total bilirubin <= 2 x ULN (except patients with documented Gilbert's syndrome); Creatinine < 2 mg/dL (or a glomerular filtration rate > 45); LVEF >= 45% on a cardiac stress test; no clinically significant ECG abnormalities, symptoms of cardiac ischemia or arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
- Stanford Cancer Institute · Stanford, California
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