Health Trials

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

ConditionsMetastatic Malignant Solid NeoplasmMetastatic MelanomaPathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IV Cutaneous Melanoma AJCC v8Recurrent Malignant Solid NeoplasmRefractory Malignant Solid NeoplasmUveal MelanomaAcral MelanomaNeuroendocrine TumorsParagangliomaPheochromocytomaAdrenocortical CarcinomaPancreatic Neuroendocrine TumorThyroid CancerBreast CancerLung AdenocarcinomaHead and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAnusha Kalbasi

About this trial

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.

Eligibility criteria

Qualifiers

Stage IIIC melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis

Stage IV melanoma including patients with known brain metastases

Other metastatic, non-central nervous system (CNS) solid tumor relapsed or refractory after all standard-of-care systemic therapies for which the patient is eligible

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)

Disqualifiers

Inability to purify >= 1 x 10^7 T cells from leukapheresis product (this does not apply to patients receiving a second infusion of IL13Ra2 CAR T cells as they will not undergo leukapheresis)

Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine

Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol

Clinically active brain metastases. Radiological documentation of absence of active brain metastases at screening is required for all patients. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment

Trial design

Treatments tested in this trial

  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Cyclophosphamide
  • Fludarabine Phosphate
  • Fludeoxyglucose F-18
  • IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells
  • Magnetic Resonance Imaging
  • Positron Emission Tomography

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators

Anusha Kalbasi

Lead sponsor

Stanford University

Sponsor institution

Melanoma Research Alliance

Collaborator

California Institute for Regenerative Medicine (CIRM)

Collaborator

City of Hope National Medical Center

Collaborator

Jonsson Comprehensive Cancer Center

Collaborator

Source ClinicalTrials.gov