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ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) to Patients With Metastatic Melanoma

NCT04904185 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-07-25

Study results available
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Summary

With the introduction of checkpoint inhibitors substantial improvements have been made in the treatment of malignant melanoma (MM). Despite this still a a subset of patients, approximately 50 %, experience no response to therapy.

One of the strategies to overcome these obstacles have been ACT with tumour infiltrating lymphocytes (TILs). Most TIL based ACT products are non-specifically expanded providing growth preference to co-infiltrated virus specific T cells, and it is currently challenging to expand T cells in an antigen-specific manner, while at the same time obtaining the ideal functional characteristics for specific and strong tumour-killing capacity with sufficient persistence.

In this phase I trial artificial antigen-presenting scaffolds for antigen-driven T cell expansion are used. These scaffolds will generate a MASE-T cell product enriched for selected specificities towards antigens known to be expressed by melanoma cells The aim of the study is to demonstrate that treatment with af MASE-T cell product i safe and feasible. Further the study will elucidate whether treament with the MASE-T cell product leads to objective responses and improves progression free survival (PFS).

Conditions

  • Malignant Melanoma

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2

DRUG

Fludarabine Phosphate

Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3

BIOLOGICAL

Multiple Antigen Specific Endogenously derived T cells

Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells

DRUG

Pembrolizumab

Pembrolizumab 2 mg/kg is administered on day -1 and on day 21. The medicine is administered over 30 minutes

Sponsors & Collaborators

  • Technical University of Denmark

    collaborator OTHER

  • Inge Marie Svane

    lead OTHER

Principal Investigators

  • Inge M Svane, Prof., M.D. · Study Director, National Center for Cancer Immune Therapy, Depth of Oncology, Herlev Hospital

  • Tine J Monberg, M.D. · Ph.d. student, National Center for Cancer Immune Therapy, Depth of Oncology, Herlev Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2024-06-07
Completion
2024-06-07

Countries

  • Denmark

Study Locations

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Entities

Drugs

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 NCT04904185 on ClinicalTrials.gov