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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
Phase 1 trial testing Lymphodepletion in Epithelial Ovarian Cancer in 55 participants. Not yet recruiting.
1 December 2027
Quick facts
| Lead sponsor | Medigene AG |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 1 July 2025 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 August 2042 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lymphodepletion — full drug profile →
- TCR-T cells (MDG1015) — full drug profile →
Conditions studied
- Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →
- Gastro-esophageal Junction Cancer — all drugs for Gastro-esophageal Junction Cancer →
- Soft Tissue Sarcoma (STS) — all drugs for Soft Tissue Sarcoma (STS) →
- Myxoid Liposarcoma — all drugs for Myxoid Liposarcoma →
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):
-
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:
- PubMed search for NCT06748872
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lymphodepletion
Trials testing the same drug.
- NCT06912529 — Axicabtagene Ciloleucel CAR T-cells in Patients With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma · Phase 2 · terminated
- NCT01659151 — Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma · Phase 2 · completed
Other recruiting trials for Epithelial Ovarian Cancer
Currently open trials in the same condition.
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07480954 — Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) · Phase 1, PHASE2 · recruiting
- NCT07218809 — AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Can · Phase 3 · recruiting
- NCT07495397 — Single-arm, Prospective Clinical Trial of Efficacy and Safety of Daphnetin Capsules Combined With TC Regimen for Targete · NA · recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
Other Medigene AG trials
Trials by the same sponsor.
- NCT03503968 — TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms · Phase 1, PHASE2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06748872 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medigene AG
- Last refreshed: 27 December 2024
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing