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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Escalating Doses
Biological/VaccineSubjects will receive a single infusion of autologous bulk TIL 13831 TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 13831 TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4 + and CD8+ T Cells expressing the TIL 13831 TCR. Subjects in Cohort 1 will receive 7.5 x 10\^6/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 2 will receive 2.5 x 10\^7/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 3 will receive 7.5 x 10\^7/kg TIL 1383I TCR transduced T cells.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Escalating DosesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Approximately 18 patients with Grade 2 through Grade 5 Adverse Events that are related to study drug, graded according to NCI CTCAE Version 4.0
Establish a recommended phase II dose of autologous T cell receptor transduced T cells by evaluating unexpected Grade 2 adverse events through Grade 5 regardless of attribution, all toxicities attributed to the cells, and all incidences of intubation including the duration and reason for intubation.
Time frame
4 weeksSecondary outcomes
1
Immunologic changes in T cell count
Change in T cell count from baseline to 4 weeks.
Time frame
Baseline and 4 weeks2
Audiologic changes of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0
Potential auditory changes from baseline to 4 weeks.
Time frame
Baseline and 4 weeks3
Ophthalmologic changes or development of Uveitis of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0
Potential visual changes from baseline to 4 weeks.
Time frame
Baseline and 4 weeks4
CT scans or physical examination from approximately 18 patients will be used to evaluate for a clinical objective response using RECIST Guideline Version 1.1
CT scan or physical examination will be used to evaluate for a clinical objective response in patients who have received transduced T Cells at scheduled time points.
Time frame
Baseline and 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Loyola University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov