Marker Therapeutics, Inc. provided an update on its Phase 1 APOLLO study for MT-601 in relapsed B-cell lymphoma, with data cutoff as of June 2025. The study treated 24 B-cell lymphoma patients across seven U.S. clinical sites, with 12 Non-Hodgkin Lymphoma (NHL) and 9 Hodgkin Lymphoma (HL) patients assessed.
In NHL patients, an objective response rate of 66% was observed, with 50% achieving a complete response at doses ranging from 100x10^6 to 200x10^6 cells. Durable responses were noted, ranging from 3 to 24 months, with 5 patients showing continued response for at least 6 months, and 3 patients for 12 months or longer.
For HL patients, the objective response rate was 78%, with 11% achieving a complete response at doses between 200x10^6 and 400x10^6 cells. The study reported a favorable safety profile across all evaluated doses, with no dose-limiting toxicities, no immune-effector cell associated neurotoxicity syndrome (ICANS), and only two reported Grade 1 cytokine release syndrome (CRS) events.
The Safety Review Committee cleared the maximum dose of 400x10^6 cells on June 17, allowing the study to advance to the dose expansion phase. This phase will focus on patients with Diffuse Large B Cell Lymphoma (DLBCL) who have relapsed after or are ineligible for CAR-T therapy, with another data update anticipated in the first half of 2026.
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