Charité – Universitätsmedizin Berlin Leads a Nine-Center IIT to Deliver First-in-Human Data for Multi-Engineered TCR-T Cell Therapy (CTC127) Targeting MAGE-A4/HLA-A1
Schönefeld, Germany – June 30, 2025 – Captain T Cell, a biotech company developing next-generation TCR-T cell therapies for solid tumors, today announced that the National Center for Tumor Diseases (NCT) has awarded funding to Charité – Universitätsmedizin Berlin for an investigator-initiated trial (IIT) evaluating CTC127, Captain T Cell’s best-in-class, multi-engineered, autologous TCR-T cell product.
Developed at Captain T Cell and the Max Delbrück Center, CTC127 recognizes the clinically validated tumor-associated antigen MAGE-A4 in patients carrying the HLA-A1 allele. The TOMATA study is a first-in-human (FIH), multicenter Phase I trial designed to enroll up to 24 patients with relapsed or refractory solid tumors across several high-unmet-need indications. First Patient In is anticipated in 2027.
“The outstanding preclinical profile of CTC127 gives us confidence that we can achieve meaningful clinical responses,” said Dr. Felix Lorenz, CEO & CSO of Captain T Cell. “Securing non-dilutive NCT funding and leveraging the proven expertise of Charité and eight other university hospitals provides a capital-efficient path to clinical proof of concept.”
In addition to Charité, eight leading German university hospitals—all with track records of rapid recruitment and high-quality execution in landmark CAR-T, TCR-T, and TIL studies—will participate in TOMATA. Their collective experience was instrumental in previous breakthroughs and is expected to accelerate patient enrollment and generate robust safety and early efficacy data.
Primary objectives of the study are to evaluate safety and to determine the recommended Phase II dose of CTC127. Secondary endpoints include pharmacokinetics and preliminary anti-tumor activity across multiple solid-tumor entities.
CTC127 is an autologous TCR-T cell therapy incorporating Captain T Cell’s proprietary toolbox of best-in-class technologies to enhance product potency in solid tumors, and it includes a shortened, automated, and scalable manufacturing process.
Based in Schönefeld, Germany, Captain T Cell is advancing a pipeline of autologous and allogeneic TCR-T cell therapies that overcome the barriers of the solid tumor microenvironment. The company spun out of the Max Delbrück Center in 2024 and is backed by leading European life science investors.
Forward-Looking Statements
This Clinical Development Update contains forward-looking statements, including statements regarding clinical development timelines and anticipated results. Actual results may differ materially. Captain T Cell undertakes no obligation to update these statements except as required by law.
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