Moderna Announces First Patient Dosed in Phase 1/2 Study of Investigational T-Cell Engager for Multiple Myeloma

On November 3, 2025 Moderna, Inc. (NASDAQ:MRNA) reported that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, the Company’s investigational mRNA-based T-cell engager (TCE) for participants with relapsed or refractory multiple myeloma (RRMM). The first dose was administered at SCRI Oncology Partners in Nashville, Tennessee, in collaboration with Sarah Cannon Research Institute (SCRI).

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mRNA-2808 is an investigational, multiplexed therapy that encodes three TCEs that target three validated myeloma-associated antigens. This novel strategy aims to address tumor heterogeneity and overcome known mechanisms of target-mediated resistance.

"This is an important milestone as it is Moderna’s first T-cell engager therapy to be dosed in a patient. Given the vast unmet needs in multiple myeloma, I believe we can help improve the lives of these patients with innovative therapies," said Dr. Kyle Holen, Head of Development, Oncology at Moderna. "Our mRNA platform uniquely allows for the multiplexing of several T-cell engager targets, designed to attack the disease from multiple angles to overcome, reduce and prevent escape mechanisms. We are proud to launch our first, of what we hope are many, T-cell engager therapies as we continue on our mission to transform cancer care for patients in need."

"Multiple myeloma is a complex cancer with many patients inevitably developing a resistance to available therapies, and attaining sustained disease control remains a challenge," said Dr. Hans Lee, Director of Myeloma Research at SCRI and Hematologist and Medical Oncologist at SCRI Oncology Partners. "At SCRI, our mission is to bring tomorrow’s breakthroughs to the patients who need them today. mRNA-based therapies could change the way we think about treating cancers like multiple myeloma, and we are proud to provide our patients with access to this clinical trial."

This study (NCT07116616) is a dose escalation study evaluating the safety and tolerability of mRNA-2808 in RRMM patients aged 18 years and older.

(Press release, Moderna Therapeutics, NOV 3, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=8697748208320019&symbol=MRNA [SID1234659290])