Actively Recruiting
Phase I Dose Escalation Study of IL13Ra2 CAR T Cells After Chemotherapy Conditioning in Patients With Metastatic Melanoma and Solid Tumors
Led by Anusha Kalbasi · Updated on 2026-03-17
18
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Anusha Kalbasi
Lead Sponsor
M
Melanoma Research Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment using modified immune cells called IL13Ralpha2 CAR T cells for patients with advanced melanoma or other metastatic solid tumors. This phase I trial aims to find the safest dose of these gene-modified cells after a chemotherapy conditioning regimen and to see how long the cells remain in the body and if they can attack cancer cells. The study also explores immune responses triggered by this therapy and monitors for side effects like cytokine release syndrome. Participants receive chemotherapy drugs cyclophosphamide and fludarabine intravenously before getting the IL13Ralpha2 CAR T cell infusion. The trial includes a dose-escalation phase followed by dose expansion. Patients undergo biopsies, CT, PET, and MRI scans at various points, and blood samples are collected throughout the study. If their disease progresses, they may get a second infusion of the CAR T cells. During the trial, patients are closely monitored for adverse events and response to treatment using scans and blood tests. Follow-up visits occur every 2 to 3 months for the first 2 years, then every 6 months for 3 years, and annually for at least 15 years to assess long-term safety and effectiveness. The main outcomes include side effects within 90 days and dose-limiting toxicity within 28 days after cell infusion.
CONDITIONS
Brief 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 incurable malignancy with stage IIIC or IV melanoma or other metastatic non-CNS solid tumors after standard therapies
- Tumor expresses IL13Ralpha2 with H-Score ≥ 50 in at least 10% of tumor tissue
- Aged 18 to less than 75 years
- ECOG performance status of 0 or 1
- At least one measurable lesion by RECIST or photographically measurable skin lesion
- Adequate blood counts and organ function within specified limits
- Melanoma patients progressed after at least one systemic therapy including immune checkpoint and BRAF/MEK inhibitors if applicable
- Willing and able to undergo leukapheresis (except for second infusion patients)
- Able to provide informed consent
You will not qualify if you...
- Unable to purify sufficient T cells from leukapheresis product (except second infusion patients)
- Known hypersensitivity to study agents including cyclophosphamide or fludarabine
- Received systemic cancer treatment within 14 days before conditioning chemotherapy
- Active brain metastases (controlled brain metastases allowed)
- Need for systemic corticosteroids or immunosuppressive drugs recently
- HIV or other immunodeficiency conditions
- Active hepatitis B or C with liver damage
- Dementia or altered mental status preventing consent
- Pulmonary function below threshold (Tiffeneau-Pinelli index < 70%)
- Significant cardiac abnormalities or arrhythmias not cleared by cardiologist
- Pregnant or breastfeeding; women must use effective contraception and have negative pregnancy tests
- Another active malignancy interfering with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants receive chemotherapy conditioning with cyclophosphamide and fludarabine phosphate intravenously over several days, followed by an infusion of IL13Ralpha2 CAR T cells. Biopsies, CT or PET and CT scans, MRI scans, and blood sample collections occur during the treatment period.
Multiple visits over approximately 1 week including drug infusions and imaging procedures
Duration - Up to 15 years
After treatment, participants are monitored with regular visits including imaging and blood sample collections to assess response and safety. Follow-up occurs every 2-3 months for 2 years, every 6 months for 3 years, then annually for at least 15 years.
Visits every 2-3 months for 2 years, then every 6 months for 3 years, then yearly visits thereafter
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here