Marker Therapeutics, Inc. (NASDAQ: MRKR) announced on October 6, 2025 that the first patient has been treated in its Phase 1 RAPID study of the Off‑the‑Shelf (OTS) multi‑antigen recognizing (MAR) T‑cell product MT‑401‑OTS. The patient received an initial dose of 100 × 10⁶ cells and was monitored for 28 days; the therapy was well tolerated with no treatment‑related adverse events reported.
The OTS program is designed to eliminate the time‑consuming manufacturing of individualized cell therapies. By using commercially available leukapheresis material from healthy donors, Marker aims to produce a product that can be administered within 72 hours, potentially expanding access to patients with aggressive diseases such as AML and MDS. The first‑patient data support the platform’s safety profile, consistent with prior MAR‑T cell studies that have shown minimal cytokine release syndrome and no neurotoxicity.
Marker has secured non‑dilutive funding from the FDA, NIH SBIR, and the Cancer Prevention and Research Institute of Texas to support the RAPID trial. The company plans to enroll additional patients and will continue to monitor safety and efficacy, with the goal of expanding the OTS approach to other indications in the future.
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