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
NCT ID: NCT06748872
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
55 participants
INTERVENTIONAL
2025-07-01
2042-08-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of MDG1015
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.
Lymphodepletion
Cylcophosamide and Fludarabine
TCR-T cells (MDG1015)
TCR-T cells (MDG1015)
Interventions
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Lymphodepletion
Cylcophosamide and Fludarabine
TCR-T cells (MDG1015)
TCR-T cells (MDG1015)
Eligibility Criteria
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Inclusion Criteria
2. Subject must have a confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer Gastric or esophageal (junction) adenocarcinoma Myxoid (round cell) liposarcoma Synovial sarcoma
3. Subject's must have tested positive for HLA-A\*02:01 genotype by a Sponsor designated central laboratory
4. Subject's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a mRNA expression by a Sponsor designated central laboratory Both ≤1 year old archival tissue or fresh biopsy are allowed
5. Subjects diagnosed with an eligible indication must have exhausted treatment options with proven survival benefit
6. Subjects must have
1. measurable disease
2. Life expectancy ≥ 3 months per Investigator's opinion
8\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 9. Adequate vital organ function 10. Adequate bone marrow function 11. Adequate coagulation profile 12. Toxicities from prior/ongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0 or Subject's baseline excluding alopecia 14. Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1 15. Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)
Exclusion Criteria
2. HLA-A\*02:02 or HLA-A\*02:03 genotype
3. Pregnant or lactating women
4. Viral serology:
1. Known infection with HIV-1/2, CMV (CMV required only for U.S. sites) or HTLV-1/2,
2. Active infection with HBV or HCV
3. Positive test for Mycoplasma or Treponema Pallidum
5. Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC (patients receiving prophylactic antibiotics are eligible)
6. Inadequate venous access for or contraindications to leukapheresis
7. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients, LDC agents, rasburicase, methylprednisolone or tocilizumab.
8. Untreated CNS metastases or active CNS metastases (progressing or requiring corticosteroids for symptoms control) and leptomeningeal disease
9. Unstable/active ulcer, varices, or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding
10. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. The following are exempt from the 1-year limit:
1. non-melanoma skin cancer
2. curatively treated localized prostate cancer
3. carcinoma in situ (e.g. cervix, bladder, breast)
11. NYHA Class ≥ II, heart failure, unstable angina, a history of recent (≤ 6 months) arrythmias, myocardial infarction or sustained (\> 30 seconds) ventricular tachyarrhythmias
12. Subjects who are dependent on dialysis
13. Subjects with a history of pulmonary embolism or deep vein thrombosis that cannot safely withhold anti-coagulant therapy from leukapheresis until 7 days after administration of MDG1015 as determined by the Investigator
14. Active autoimmune disease requiring systemic therapy except for adequately controlled Type 1 diabetes mellitus, autoimmune hypothyroidism or Grave's disease
15. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant
Specific to GAC/GEJ Subjects:
16. Positive history of esophageal or gastric resection that the Investigator considers is at increased risk of bleeding or perforation
18 Years
ALL
No
Sponsors
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Medigene AG
INDUSTRY
Responsible Party
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Principal Investigators
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David Dr. Zhen, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch Cancer Center
Locations
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Fred Hutch Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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2024-516787-28-00
Identifier Type: CTIS
Identifier Source: secondary_id
2024-516787-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CD-TCR-004
Identifier Type: -
Identifier Source: org_study_id