ACT-TIL and ANV419 for Advanced Melanoma.
NCT05869539 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-02-27
Summary
In this study we aim to investigate safety and tolerability of tumor-infiltrating lymphocytes (TIL) adoptive cell therapy (ACT) incorporation in-vivo TIL expansion with ANV419 in patients with advanced melanoma
Conditions
Interventions
- DRUG
-
Combination of Tumor-infiltrating lymphocyte transfer with ANV419
The study uses a personalized IMP (investigational medicinal product), i.e. TIL product in combination with ANV419. Day 0: Autologous TIL: (minimum 5 x 10\^9 and up to 2x 10\^11 lymphocytes) administered intravenously over 20 to 30 minutes. Day 0: Intravenous treatment with ANV419 at 243 μg/kg 2 hours after the TIL infusion. Actual body weight will be used to calculate the dose of ANV419. Day14: Intravenous treatment with ANV419 at 243 μg/kg. Actual body weight will be used to calculate the dose of ANV419.
Sponsors & Collaborators
-
Anaveon AG
collaborator INDUSTRY -
University Hospital, Basel, Switzerland
lead OTHER
Principal Investigators
-
Heinz Läubli, Prof. · University Hospital, Basel, Switzerland
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-21
- Primary Completion
- 2026-04-30
- Completion
- 2026-06-30
Countries
- Switzerland
Study Locations
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