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.
Adult, ≥ 18 years of age and weigh ≥ 40 kg for Dose levels 1-3 and ≥ 50 kg for Dose level 4
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
Subject's must have tested positive for HLA-A*02:01 genotype by a Sponsor designated central laboratory
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
Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
HLA-A*02:02 or HLA-A*02:03 genotype
Pregnant or lactating women
Known infection with HIV-1/2, CMV (CMV required only for U.S. sites) or HTLV-1/2,
Single group
Lymphodepletion
DrugCylcophosamide and Fludarabine
TCR-T cells (MDG1015)
Biological/VaccineTCR-T cells (MDG1015)
DE Segment: Adverse Events and Dose Limiting Toxicities (Safety and Tolerability)
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)
Incidence of (S)AEs by type, grade and duration
Objective response rate (ORR)
Proportion of Subjects having a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
Correlation of blood levels and the onset and/or severity of IP-related toxicities
Correlation of certain blood levels in serum over time and any correlation between these levels and the onset and/or severity of IP-related toxicities
Clinical benefit rate (CBR)
Proportion of Subjects having a sustained confirmed stable disease (SD) or a confirmed PR or CR for any duration of time per RECIST v1.1
Overall survival (OS)
The interval between MDG1015 infusion and date of death by any cause
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This trial is not recruiting at the moment. You can still explore other options:
