GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies
The formal safety review of Cohort 3 (5ug/kg/day) has been successfully completed with no safety or tolerability issues observed, allowing advancement into Cohort 4 with a dose of 10 ug/kg/day
Actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks
Cohort 4 dose is potentially more reflective of the clinical efficacy threshold given positive trend in observations on multiple immunological biomarkers from the previous six patients in Cohorts 1 through 3, the absence of dose limiting toxicities, and the associated lower dose levels
Next update expected in Q1 2026, as well as continued dose escalation (up to 100ug/kg/day) in 3 additional cohorts if necessary
Excerpt from the Press Release:
SAN FRANCISCO, CALIFORNIA, Oct. 23, 2025 (GLOBE NEWSWIRE) — GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE® natural killer (NK) cell engager platform, today announced successful completion of the Cohort 3 formal safety review with no safety or tolerability issues observed and advancement into Cohort 4 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
The six patients in Cohorts 1 through 3 have been successfully treated with GTB-3650 and the formal safety review of Cohort 3 showed no safety or tolerability issues observed. This has allowed progression to actively screening patients for Cohort 4. With a dose of 10 ug/kg/day, Cohort 4 is more reflective of the potential efficacy threshold. The Phase 1 trial protocol allows for three additional cohorts with much higher dose levels ranging from 25 ug/kg/day with Cohort 5, 50 ug/kg/day with Cohort 6 and 100 ug/kg/day for Cohort 7, if necessary. The company anticipates providing its next update on the trial in Q1 2026.
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