Actively Recruiting
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
Led by Anusha Kalbasi · Updated on 2026-03-17
18
Participants Needed
3
Research Sites
51 weeks
Total Duration
On this page
Sponsors
A
Anusha Kalbasi
Lead Sponsor
M
Melanoma Research Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IIIC or IV melanoma or other metastatic, non-CNS solid tumor that is relapsed or refractory after standard therapies
- Tumor shows IL13Ralpha2 expression by immunohistochemistry with H-Score >= 50 in at least 10% of tumor and 2 high-power fields
- Age 18 to less than 75 years
- ECOG performance status 0 or 1
- At least one measurable lesion by RECIST criteria or measurable skin lesion by photography
- Absolute neutrophil count >= 1 x 10^9 cells/L within 30-60 days prior and re-evaluated within 14 days before chemotherapy
- Platelets >= 75 x 10^9/L within 30-60 days prior and re-evaluated within 14 days before chemotherapy
- Hemoglobin >= 9.5 g/dL within 30-60 days prior and re-evaluated within 14 days before chemotherapy
- AST and ALT <= 2.5 times upper limit of normal within 30-60 days prior and re-evaluated within 14 days before chemotherapy
- Total bilirubin <= 2 times upper limit of normal, except Gilbert's syndrome, within 30-60 days prior and re-evaluated within 14 days before chemotherapy
- Creatinine < 2 mg/dL or glomerular filtration rate > 45 within 30-60 days prior and re-evaluated within 14 days before chemotherapy
- Patients with melanoma progressed after >= 1 line of systemic therapy, including immune checkpoint inhibitor and targeted therapy if BRAF mutation
- Willing and able to undergo at least one leukapheresis procedure (except for second infusion patients)
- Able and willing to provide written informed consent
You will not qualify if you...
- Unable to purify >= 1 x 10^7 T cells from leukapheresis product (except for second infusion patients)
- Known hypersensitivity to study agents, including cyclophosphamide or fludarabine
- Received systemic cancer treatment including immunotherapy within 14 days before conditioning chemotherapy
- Clinically active brain metastases; controlled brain metastases allowed
- Need for systemic corticosteroids or immunosuppressive drugs recently, excluding physiologic steroid replacement or standard inhaled/topical steroids
- HIV positive or other immune deficiency increasing infection risk
- Hepatitis B or C with ongoing liver damage
- Dementia or altered mental status preventing consent or compliance
- Pulmonary function with Tiffeneau-Pinelli index less than 70% predicted
- History of significant ECG abnormalities or cardiac arrhythmias and left ventricular ejection fraction under 45%
- Certain conduction delays, bradycardia, tachycardia, or arrhythmias unless cleared by cardiologist
- Pregnancy or breastfeeding; females must be surgically sterile, postmenopausal, or use effective contraception with negative pregnancy tests
- Active second malignancy interfering with study assessments
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
Stanford Cancer Institute
Stanford, California, United States, 93405
Actively Recruiting
Research Team
L
Lucie M Cutler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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