EPITOME-1015-I: MDG1015 TCR-T Cell Therapy in Synovial Sarcoma andOther Advanced Solid Tumors
Trial ID: NCT06748872
Phase: Phase 1 (dose escalation and expansion)
Status: Other, Not yet recruiting
Last Update Posted: December 2024
Eligibility: Adults aged 18 and older with advanced synovial sarcoma, myxoid/round cell liposarcoma, gastric cancer, or ovarian cancer whose tumors express NY-ESO-1 and/or LAGE-1a and are HLA-A*02:01 positive. Patients must have exhausted standard treatment options.
Overview: This Phase 1 trial evaluates MDG1015, a third-generation TCR-T cell therapy using a patient’s own T-cells engineered to target NY-ESO-1 and LAGE-1a antigens. MDG1015 incorporates a PD1-41BB costimulatory switch protein designed to overcome immune suppression by converting the tumor’s “stop” signal into an activation signal for the T-cells. The trial begins with dose escalation to establish safety and optimal dosing, followed by an expansion phase to evaluate early anti-tumor activity. Principal Investigator: David Zhen, MD, Fred Hutch Cancer Center.
Preliminary Effectiveness: Preclinical studies have demonstrated potent tumor-killing activity by MDG1015, including against tumors with high PD-L1 expression, and improved T-cell fitness through a streamlined 6-day manufacturing process. These findings, alongside results from earlier NY-ESO-1-targeted therapies, suggest MDG1015 could induce strong and durable anti-tumor responses.
Study Contact: Medigene AG
- Kirsty Crame, MD: k.crame@medigene.com / +49 892 000 330
- Marianne Seibt: m.seibt@medigene.com
Treatment Centers:
United States
- Fred Hutch Cancer Center, Seattle, WA