Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-89
SponsorLoyola University
About this trial
Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.
Eligibility criteria
Qualifiers
Patients must have a diagnosis of metastatic melanoma which is evaluable either clinically or radiologically.
Patients must be 18 years of age or older.
Patients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelines.
Patients must have a performance status (PS) of 0 or 1 ECOG PS scale.
Disqualifiers
Special classes of subjects such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable.
ECOG performance status of 2 or greater.
Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior three months that was not controlled with surgery or radiotherapy.
Patients taking steroids for disease control or pain management
Trial design
Treatments tested in this trial
- Escalating Doses
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Loyola University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov