CREATE Medicines Achieves Groundbreaking First-in-Human Results for MT-302 Immunotherapy Trial
CREATE Medicines Achieves Groundbreaking First-in-Human Results for MT-302 Immunotherapy Trial
In a significant breakthrough for cancer treatment, CREATE Medicines Inc., previously known as Myeloid Therapeutics, has announced compelling first-in-human results from its Phase 1 MYE Symphony trial. The trial evaluated MT-302, an innovative mRNA-LNP-encoded CAR therapy targeting TROP2 in patients suffering from advanced solid tumors. These promising results were presented at the Society for Immunotherapy of Cancer's 40th Anniversary Annual Meeting held in Cambridge, Massachusetts.
Key Findings of the Trial
The trial involved 27 participants, all with advanced TROP2-positive solid tumors, administered across varying doses of MT-302. Notably, the outcomes reflect both safety and a signal of antitumor efficacy:
- - Safety Profile: The therapy exhibited a manageable safety profile, commonly associated with immune cell activation. About 51.9% of patients experienced low-grade cytokine release syndrome (CRS), a typical immune response, with no occurrences of grade 3 or higher CRS events reported. The maximum tolerated dose identified was 0.10 mg/kg, with a single Grade 4 immune effector cell-associated neurotoxicity syndrome (ICANS) event occurring at the highest tested dose of 0.15 mg/kg.
- - Pharmacokinetics: The pharmacokinetics showed a terminal half-life of 45-50 hours for the administered pegylated and ionizable lipids.
- - Biological Activity: The presence of CAR-positive myeloid cells in the tumors, accompanied by robust T-cell infiltration and cytokine induction—namely IFNγ and CXCL9/10—indicated active immune response and remodeling within the tumor microenvironment. Importantly, a correlation between tumor burden change and the CXCL9/S.P.P1 ratio was observed, highlighting the therapy's pro-inflammatory effects.
- - Clinical Signal: Of particular interest was the confirmed partial response in a patient suffering from hormone receptor-positive breast cancer, who remained on treatment for 16 months receiving a total of 20 doses.
Dr. Rasha Cosman, the Head of the Early Phase Clinical Trials Unit at The Kinghorn Cancer Centre, stated, "These data give crucial insights into how in vivo programmed myeloid cells interact within tough tumor environments. The observed remodeling, combined with the manageable safety profile and early signs of anti-tumor activity in heavily pre-treated patients, presents a promising avenue in fields where immune infiltration has historically faced challenges."
Implications for Future Research
Matt Maurer, M.D., Chief Medical Officer of CREATE Medicines, emphasized that these results mark a pioneering moment as the first demonstration of an in vivo CAR therapy that achieves real tumor penetration and measurable biological activity within solid tumors. The ability of MT-302 to maintain a manageable safety profile while allowing repeat dosing signifies a promising step towards clinical advancements in this area. The next steps involve continued testing, with a front-line solid tumor trial being launched that combines MT-302 with standard frontline treatment regimens, named the SPaCE-MT trial.
About CREATE Medicines
Founded with a vision to establish cutting-edge therapies, CREATE Medicines is at the frontier of clinical-stage biotechnology. By leveraging its proprietary mRNA-LNP platform, the company is addressing the need for scalable and repeatable off-the-shelf immunotherapies, effectively advancing a pipeline of in vivo CAR therapies designed to improve outcomes for patients suffering from cancer and other chronic conditions. The success of MT-302 could pave the way for a new generation of effective cancer treatments.
Conclusion
As CREATE Medicines continues to push the boundaries of medical science and immunotherapy, the implications of these findings could be transformative for cancer treatment. The ability to program immune responses in vivo offers hope not just for patients battling solid tumors but also for the future of personalized medicine. Keep an eye on this evolving story as more results emerge from ongoing clinical trials.
Presentation Details
- - Title: First-in-Human Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of mRNA-LNP MT-302 In Vivo CAR Therapy in Solid Tumors
- - Presenting Author: Dr. Rasha Cosman, The Kinghorn Cancer Centre, St. Vincent's Hospital, Darlinghurst NSW, Australia
- - Session Date and Time: November 7, 2025, 11:30 AM - 12:15 PM ET
- - Location: Gaylord National Resort & Convention Center, Potomac Ballroom, National Harbor, MD
For more information on CREATE Medicines and their groundbreaking research, visit CREATE Medicines.
Topics Health）
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