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To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma

NCT06204991 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-24

No results posted yet for this study

Summary

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.

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV
  • Melanoma

Interventions

BIOLOGICAL

ADP-TILIL7

Autologous tumor infiltrating lymphocytes genemodified (by a lentiviral vector) to produce IL-7 upon antigen engagement

DRUG

Cyclophosphamide

Lymphodepleting Chemotherapy

DRUG

Fludarabine Phosphate

Lymphodepleting Chemotherapy

DRUG

Proleukin

IL-2

Sponsors & Collaborators

  • Adaptimmune

    collaborator INDUSTRY

  • Inge Marie Svane

    lead OTHER

Principal Investigators

  • Inge Marie Svane, Prof., M.D. · Study Director, CCIT-DK, Depth of Oncology, Herlev Hospital

  • Cecilie D Vestergaard, M.D. · Clinical research assistant, CCIT-DK, Depth of Oncology, Herlev Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-03-01
Completion
2028-04-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204991 on ClinicalTrials.gov