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

Part of paid clinical trials in Duarte, California.

Sponsor
Anusha Kalbasi
Study ID
NCT04119024
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine Phosphate — DRUG
    Given IV
  • Fludeoxyglucose F-18 — OTHER
    Undergo FDG-PET/CT scan
  • IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (chemotherapy, IL13Ralpha2)
    Patients may receive cyclophosphamide IV over 60 minutes on days -5 to -3 and fludarabine phosphate IV over 15-30 minutes on days -5 to -2. Patients then receive IL13Ralpha2 CAR T cells IV on day 0. Patients also undergo biopsy at baseline and on study, CT, or PET and CT scan at screening and on study, magnetic resonance imaging (MRI) throughout the trial, and collection of blood samples throughout the trial. Patients with disease progression may receive a second cycle with an infusion of IL13Ralpha2 CAR T cells.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 90 days from the day of chimeric antigen receptor (CAR)-transgenic cell infusion ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Claudia Aceves
[email protected]
Yan Xing, MD, Phd (PRINCIPAL_INVESTIGATOR)
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Christy Sidhu
[email protected]
310-206-5087
Antoni Ribas, MD, PhD (PRINCIPAL_INVESTIGATOR)
Stanford Cancer InstituteStanfordCalifornia93405
Lucie Cutler
[email protected]
Allison Betof Warner, MD, PhD (PRINCIPAL_INVESTIGATOR)

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OncologyBreast oncologyWomen's healthENTLung oncologyLung diseaseSkin cancerDermatology
By research site
City of Hope· Duarte, CAUCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAStanford Cancer Institute· Stanford, CA

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