Carisma Therapeutics Begins Phase 1 Trial of CT-0525 in First Patient

Carisma Therapeutics Inc., a clinical-stage biopharmaceutical company, has announced the commencement of a groundbreaking Phase 1 clinical trial for CT-0525, an innovative CAR-Monocyte cellular therapy designed to treat solid tumors overexpressing the human epidermal growth factor receptor 2 (HER2). This marks the first instance of a CAR-Monocyte therapy being evaluated in humans within the context of solid tumors. The trial is expected to provide initial data by the end of 2024.

CT-0525 represents a first-in-class, ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) therapy. It aims to address the therapeutic needs of patients with HER2-overexpressing solid tumors, particularly those whose disease has progressed despite standard treatments. The therapy is designed to improve upon the company's initial CAR-Macrophage program by offering enhanced manufacturing speed, higher dosing capabilities, and increased effectiveness in tumor infiltration and persistence.

Eugene P. Kennedy, M.D., the Chief Medical Officer of Carisma, highlighted the significance of dosing the first patient in the trial, emphasizing the potential of the CAR-M platform to make a substantial impact on patient outcomes. He noted that pre-clinical data suggests this next-generation approach could offer more significant benefits compared to previous CAR-Macrophage therapies.

Davendra Sohal, M.D., M.P.H., a Professor of Medicine at the University of Cincinnati Cancer Center, expressed optimism about CT-0525's potential to provide new treatment options for patients with HER2-overexpressing solid tumors. Dr. Sohal underscored the urgent need for innovative therapies in this area, given the common challenge of disease progression. The University of Cincinnati Cancer Center is the first site to treat a patient with CT-0525, and Dr. Sohal looks forward to continued collaboration with Carisma and other centers to accelerate patient enrollment in the trial.

The open-label Phase 1 clinical trial aims to evaluate the safety, tolerability, and manufacturing feasibility of CT-0525. Participants will include patients with locally advanced or metastatic HER2-overexpressing solid tumors that have not responded to standard therapies. The study will feature two dose escalation cohorts to assess the therapy's impact. Details about the trial are available under the identifier NCT06254807.

Carisma plans to present a "Trial in Progress" poster detailing the design of the CT-0525 Phase 1 trial at the upcoming American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, IL, from May 31 to June 4, 2024.

Carisma Therapeutics Inc. is dedicated to developing innovative immunotherapies by leveraging its proprietary macrophage and monocyte cell engineering platform. The company's focus is on creating transformative treatments for cancer and other serious diseases. Based in Philadelphia, PA, Carisma's platform aims to harness the crucial roles of macrophages and monocytes in the immune system to develop effective therapies.

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