MDG1015 for Ovarian Cancer

(EPITOME-1015-I Trial)

Overseen By Kirsty Dr. Crame, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medigene AG

Must not be taking: Corticosteroids, Anticoagulants

Disqualifiers: Uncontrolled disorders, HIV, HBV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

55 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a history of pulmonary embolism or deep vein thrombosis, you must be able to safely stop anti-coagulant therapy for a period around the treatment.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis and LDC

Leukapheresis of mononuclear cells and lymphodepletion chemotherapy (LDC) prior to MDG1015 infusion

1-2 weeks

Treatment

Participants receive a single infusion of MDG1015 followed by at least 3 days of in-patient safety monitoring

1 week

1 visit (in-patient)

Post-treatment Follow-up

Participants are monitored regularly for safety and efficacy assessments

12 months

Regular visits (out-patient)

Long-term Follow-up

Participants enter long-term follow-up for safety and survival assessments

15 years

Treatment Details

Interventions

• MDG1015

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+