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NCT06748872 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by MediGene.
- Not yet
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT06748872: Clinical Trial Phase 1 study, sponsored by MediGene.
NCT06748872 is a Phase 1 study that has not yet begun recruiting, run by MediGene. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06748872, a Phase 1 study, has not yet begun recruiting, sponsored by MediGene.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Incidence and severity of adverse events to establish RP2D measured by dose limiting toxicities (DLTs) up to 28 days post infusion
Interventions
- DRUG Lymphodepletion
- BIOLOGICAL TCR-T cells (MDG1015)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2042-08-01 |
| Phase | Phase 1 |
What is known before NCT06748872 opens enrollment
NCT06748872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Lymphodepletion is the first listed.
NCT06748872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06748872 about?
NCT06748872 is a clinical study titled "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". 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, gastroeso...
What is the current status of trial NCT06748872?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2025-07-01. Estimated completion is 2042-08-01.
What interventions are being tested in trial NCT06748872?
The interventions under investigation include: Lymphodepletion (DRUG), TCR-T cells (MDG1015) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06748872?
This trial is sponsored by MediGene, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06748872's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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