To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInge Marie Svane
About this trial
The primary objective of this Phase 1 clinical trial is to evaluate the feasibility and tolerability of a novel generation of gene-modified tumor infiltrating lymphocytes (TILs) in a cohort of 10 patients aged 18-75 diagnosed with unresectable or metastatic melanoma. TILs will undergo transduction with the Interleukin-7 (IL-7) gene, for IL-7 production upon antigen engagement.
Participants will undergo:
* screening * tumor operation following autologous TIL production (incl. transduction) - takes approximately 4-6 weeks * admission for lymphodepleting chemotherapy (Cyclophosphamide and Fludarabine phosphate), TIL infusion and high-dose IL-2 infusions for a maximum of 6 doses * Following treatment, patients will undergo systematic and regularly planned assessments, encompassing clinical evaluation, biochemistry analyses, and PET/CT scans. This thorough follow-up regimen will be continued until any of the following events occur: progressive disease, withdrawal from study, or end of study, which spans a duration of 15 years for trials involving genetically modified organisms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All the criteria listed in the following need to be met before patient inclusion.
Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV).
Progressive disease after standard treatment with PD-1 check-point inhibition or combination of aforementioned with CTLA-4 check-point inhibition.
Age: 18 - 75 years at time of signed Informed consent.
Disqualifiers
Patients will be excluded if they meet one of the criteria's listed below
Cytotoxic chemotherapy: Washout period 3 weeks before TR and LDC
Small molecules/TKI: Washout period 1 week before TR and LDC
Immune therapy (monoclonal AB therapy, CPI and biologics): 2 weeks before TR and LDC
Trial design
Design model
Single group
Treatments tested in this trial
ADP-TILIL7
Biological/VaccineAutologous tumor infiltrating lymphocytes genemodified (by a lentiviral vector) to produce IL-7 upon antigen engagement
Cyclophosphamide
DrugLymphodepleting Chemotherapy
Fludarabine Phosphate
DrugLymphodepleting Chemotherapy
Proleukin
DrugIL-2
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Tumor-infiltrating lymphocytes genemodified with IL-7 gene for IL-7 production upon Ag engagementExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Tolerability of the treatment
Fraction of subjects experiencing grade \>/= 3 AE
Time frame
Through study completion, an average of 1 year2
Feasibility of the treatment
Measured by the number of subjects who undergo surgery and succesfully undergo ADP-TILIL7-infusion
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Objective response rate
Defined as the proportion of subjects who have a partial or complete response to therapy. Response evaluation criteria in solid tumors, RECIST 1.1. criterias assesed by CT scan
Time frame
Until progression up to 15 years2
Overall survival
Time from initiation of treatment to death
Time frame
15 years3
Progression free survival
Time from initiation of treatment until first evidence of disease progression or death
Time frame
Until progression or death up to 15 years4
Duration of response
Time from initiation of treatment to disease progression or death in subjects who achieve complete or partial response
Time frame
15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov