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NCT06748872: EPITOME-1015-I

EPITOME-1015-I: a Study to Investigate the Safety and Tolerability of MDG1015 in Patients with Epithelial Ovarian Cancer, Gastroesophageal Adenocarcinoma, Round Cell Liposarcoma And/or Synovial Sarcoma

Not yet recruiting Phase 1 Last updated 27 December 2024
What this trial tests

Phase 1 trial testing Lymphodepletion in Epithelial Ovarian Cancer in 55 participants. Not yet recruiting.

Timeline
1 July 2025
Primary endpoint
1 December 2027
1 August 2042

Quick facts

Lead sponsorMedigene AG
PhasePhase 1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment55
Start date1 July 2025
Primary completion1 December 2027
Estimated completion1 August 2042
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medigene AG — full company profile →

Who can join

18 and older, any sex, with Epithelial Ovarian Cancer or Gastro-esophageal Junction Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

MDG1015 is a third generation TCR-T therapy product targeting NY-ESO-1/LAGE-1a armored and enhanced by the PD1-41BB costimulatory switch protein (CSP). The study purpose is to establish the safety, tolerability and preliminary efficacy of MDG1015 in patients with epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma and/or synovial sarcoma that expresses NY-ESO-1 and/or LAGE-1a. The main questions this clinical trial aims to answer are: Can this TCR-T therapy MDG1015 be given to patients safely? What is the optimal dose of the TCR-T therapy MDG1015? If and what side effects do participants experience after receiving the TCR-T therapy MDG1015? Do participants experience a potential disease response after receiving the TCR-T therapy MDG1015? Participants will: Receive (in most cases) 1 single infusion of MDG1015 at a pre-defined dose level and will be followed up regularly up to 1 year. After one year, participants will enter the long term follow-up part up to 15 years after being treated. Any side effects and/or potential disease response will be documented during this period.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. T-cell receptor therapy in ovarian cancer: concepts and challenges.
    Wang X, Li Z, Zhang M, Yu Y, et al · · 2025 · PMID 41233888 · DOI 10.1186/s13048-025-01831-y

Verify or expand the search:

Other trials of Lymphodepletion

Trials testing the same drug.

Other recruiting trials for Epithelial Ovarian Cancer

Currently open trials in the same condition.

Other Medigene AG trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06748872.

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