MDG1015 for Ovarian Cancer, Gastroesophageal Adenocarcinoma, and Sarcomas

This study is testing a new treatment called MDG1015, a type of cell therapy (TCR-T cells), for people with certain advanced cancers: epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma, or synovial sarcoma. Before receiving MDG1015, you will receive other medications (Cylcophosamide and Fludarabine) to prepare your body. Researchers want to find out if MDG1015 is safe, what side effects it might cause, and the best dose to give. They also want to see if it can help improve your condition. To join, you must be at least 18 years old and have one of the specific cancer types mentioned that expresses NY-ESO-1 and/or LAGE-1a. The study is currently enrolling about 55 participants, but its overall status is unclear.

Study design
This is an interventional study with an anticipated enrollment of 55 participants. It aims to determine the safest and most effective dose of MDG1015.
What's involved
You would undergo screening, a procedure to collect your immune cells (leukapheresis), receive the preparatory medications, and then a single infusion of MDG1015. You will stay in the hospital for at least 3 days after the infusion for monitoring.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will have regular follow-up visits for safety and effectiveness for 12 months, and then long-term follow-up for up to 15 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06748872

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
PHASE1Ages 18+InterventionalTreatment
Medigene AG
~55 participants
Updated 2024-12-27 on ClinicalTrials.gov
What's tested:LymphodepletionTCR-T cells (MDG1015)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
DE Segment: Adverse Events and Dose Limiting Toxicities (Safety and Tolerability)
Measured over 28 days
+1 more outcome measured
Epithelial Ovarian Cancer
Gastro-esophageal Junction Cancer
Soft Tissue Sarcoma (STS)
Myxoid Liposarcoma
Synovial Sarcoma
1 sites across 1 states
Washington1
  • David Dr. Zhen, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch Cancer Center

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  • DE Segment: Adverse Events and Dose Limiting Toxicities (Safety and Tolerability)28 days

    Incidence and severity of adverse events to establish RP2D measured by dose limiting toxicities (DLTs) up to 28 days post infusion

  • Exp Segment: Adverse Events (Safety)12 months

    Incidence of (S)AEs by type, grade and duration