MDG1015 for Ovarian Cancer

(EPITOME-1015-I Trial)

Recruiting in Palo Alto (17 mi)

Overseen by David Dr. Zhen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Medigene AG

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Dr. Zhen, MD

Principal Investigator

Fred Hutch Cancer Center

Eligibility Criteria

This trial is for patients with specific cancers (epithelial ovarian, gastroesophageal adenocarcinoma, round cell liposarcoma, synovial sarcoma) that express NY-ESO-1/LAGE-1a. Participants must be able to receive a single infusion of the study drug and commit to long-term follow-up.

Inclusion Criteria

I am fully active or can carry out light work.

My vital organs are functioning well.

My bone marrow is working well.

Exclusion Criteria

I have untreated or active brain metastases or leptomeningeal disease.

I rely on dialysis for kidney function.

I cannot stop my blood thinner safely for a week after a specific treatment, as decided by my doctor.

Treatment Details

Interventions

• MDG1015 (CAR T-cell Therapy)

Trial Overview The trial tests MDG1015, a TCR-T therapy targeting certain cancer antigens with an added costimulatory switch protein. It aims to determine safety, optimal dosage, side effects, and potential disease response after treatment.

Participant Groups

Group I: Administration of MDG1015 Experimental Treatment 2 Interventions

MDG1015 is a first-in-class, 3rd generation TCR-T therapy consisting of autologous, patient-derived CD8+ T cells that are transduced with a New York esophageal squamous cell carcinoma-1 (NY-ESO-1)/ L antigen family member-1a (LAGE-1a)-specific, human leukocyte antigen (HLA)-A\*02:01-restricted T cell receptor (TCR) and the costimulatory switch protein (CSP) programmed cell death protein 1 (PD1)-41BB administered following lymphodepletion chemotherapy.

Who Is Running the Clinical Trial?

Medigene AG

Lead Sponsor

Trials

5

Recruited

130+