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GT Biopharma (NASDAQ: GTBP) said Phase 1 enrollment for GTB-3650 in r/r CD33‑expressing hematologic malignancies is progressing on schedule.Both patients in Cohort 3 have begun treatment with no dose‑limiting toxicities or tolerability concerns observed to date. The first Cohort 3 patient showed immune activation biomarkers consistent with activity seen in Cohorts 1–2. If Cohort 3 completes without new safety findings, dosing will escalate; Cohort 4 initiation is planned by year‑end 2025 with additional data updates anticipated in Q1 2026. The protocol allows up to ~14 patients across seven cohorts with doses from 1.25 μg/kg/day to 100 μg/kg/day, dosed in two‑week on/off cycles for up to four months.

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YouTube video by Metal Blade Records

YouTube video by Metal Blade Records

GT Biopharma (NASDAQ: GTBP) has reported its Q2 2025 financial results and provided clinical updates. The company's GTB-3650 TriKE® Phase 1 trial has successfully completed Cohorts 1 and 2, advancing to Cohort 3 with the fifth patient now receiving treatment. The trial is evaluating GTB-3650 in patients with CD33 expressing hematologic malignancies.Financial highlights include cash position of $5.3 million as of June 30, 2025, expected to fund operations into Q1 2026. The company reported reduced quarterly losses with a net loss of $1.4 million, down from $3.7 million in Q2 2024, driven by significant reductions in R&D expenses to $400,000 (down from $1.8M) and SG&A expenses to $1.1 million (down from $2.0M).Additionally, GT Biopharma plans to submit an IND application for GTB-5550 TriKE® in Q4 2025 for the treatment of B7H3 positive solid tumors.

GT Biopharma (NASDAQ: GTBP) has advanced to Cohort 3 in its Phase 1 clinical trial of GTB-3650, following successful safety reviews of Cohorts 1 and 2. GTB-3650, a second-generation TriKE® natural killer cell engager, is being evaluated for treating relapsed/refractory CD33-expressing hematologic malignancies.The trial's first four patients have shown encouraging early results, demonstrating GTB-3650's ability to activate and expand NK cells, with multiple blood biomarker assays indicating heightened immune activity. The study plans to enroll up to 14 patients across seven cohorts, with dosing in two-week cycles for up to four months. Initial Phase 1 results are expected later in 2025.

Early trial data shows GTB-3650 safety confirmed and immune activation signals detected. Phase 1 advances to second cohort for blood cancer treatment. See full results.