GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies
MWN-AI** Summary
GT Biopharma, Inc. (NASDAQ: GTBP) has shared a positive update on its Phase 1 clinical trial for GTB-3650, targeting relapsed or refractory (r/r) CD33-expressing hematologic malignancies. As of October 8, 2025, patient enrollment for the trial is progressing smoothly, with both patients in Cohort 3 successfully commencing treatment without any dose-limiting toxicities or tolerability issues reported so far. The first patient in this cohort has exhibited encouraging signs of immune activation, paralleling the immune responses seen in participants from the earlier lower-dose cohorts.
Upon successful assessment of safety in Cohort 3, the trial is set to advance to Cohort 4 dosing, anticipated to begin by the end of 2025. The trial protocol allows for flexibility, potentially accommodating up to seven cohorts of participants, ensuring comprehensive data collection. Findings from this ongoing study are expected to inform future dosing strategies, as the aim is to escalate doses in a manner that translates immune activation into therapeutic efficacy.
The trial's key parameters include evaluating safety, pharmacokinetics, pharmacodynamics, and the in vivo expansion of endogenous natural killer (NK) cells, with treatment cycles administered in two-week blocks. Patients will receive doses escalating from 1.25 µg/kg/day in Cohort 1 to 100 µg/kg/day in Cohort 7.
As GT Biopharma moves forward, additional data updates are scheduled for release in Q1 2026. The company continues to leverage its proprietary TriKE® platform to enhance NK cell activity, aimed at developing innovative immuno-oncology therapies. For further details, interested parties can refer to clinicaltrials.gov under the identifier NCT06594445.
MWN-AI** Analysis
GT Biopharma, Inc. (NASDAQ: GTBP) has made significant progress with its Phase 1 trial of GTB-3650 for the treatment of relapsed or refractory CD33 expressing hematologic malignancies. With both patients in Cohort 3 initiating treatment without any dose-limiting toxicities reported thus far, the company is on track for successful advancement through the trial stages. Positive immune activation signals seen in the first patient of Cohort 3 mirror those observed in previous cohorts, bolstering the potential for clinical efficacy.
As the trial aims to assess safety, pharmacokinetics, and clinical activity across an extended dosing range (1.25 to 100 µg/kg/day), the results poised for release in Q1 2026 from the ongoing Cohort 3 assessment are crucial. Assuming robust results, progression to Cohort 4 by year-end 2025 will mark a key milestone, emphasizing the product's favorable tolerability and dosage flexibility—allowing for up to seven cohorts to help ascertain optimal dosing levels.
For investors, GT Biopharma presents an opportunistic buy, especially for those with a high-risk tolerance. Given the early-stage nature of the drug's development and the significant advancements in immuno-oncology, GTBP shares could see appreciation in response to positive trial outcomes. However, a careful eye should be kept on the regulatory landscape and market competition in this space, particularly how GTB-3650 stacks up against existing and emerging therapies.
In light of the favorable enrollment updates and interim results, stakeholders might consider accumulating shares in anticipation of the potential upward momentum that could follow the critical data updates slated for early 2026. As always, maintaining a diversified portfolio and closely monitoring developments within the company will be prudent strategies for navigating this high-stakes biotech environment.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
The Company is well on track with Phase 1 enrollment now that both patients in Cohort 3 have successfully initiated treatment with no evidence of dose-limiting toxicities or tolerability concerns to date
The first patient in Cohort 3 has shown promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts; additional update anticipated by year-end
Upon successful completion of the Cohort 3 safety assessment, the trial will continue to dose escalate with initiation of Cohort 4 dosing planned by year-end 2025, and flexibility to dose up to 7 cohorts if necessary; additional data updates anticipated in Q1 2026
SAN FRANCISCO, CALIFORNIA, Oct. 08, 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 that enrollment in the dose escalation cohorts of the Phase 1 trial, evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies, is well on track.
Enrollment in Cohorts 1 and 2 were successfully completed; both patients in Cohort 3 have now initiated treatment with no evidence of dose-limiting toxicities or safety concerns to date. The level of immune activation observed from multiple biomarkers in the first patient of Cohort 3 is consistent with the evidence of heightened immune activity in the first four patients from Cohorts 1 and 2. Assuming Cohort 3 is completed with no new safety findings, the trial will continue to dose-escalate into the higher ranges of GTB-3650 anticipated to be necessary to translate heightened immune activation into clinically meaningful evidence of therapeutic activity. Initiation of dosing in Cohort 4 is planned by year-end 2025 and additional data updates are anticipated in Q1 2026.
The Phase 1 protocol allows evaluation of GTB-3650 in up to approximately 14 patients (two patients in each of seven cohorts), with doses ranging from 1.25ug/kg/day in Cohort 1 to 100ug/kg/day in Cohort 7. GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off (defining a treatment cycle), for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. More details can be found on clinicaltrials.gov with the identifier: NCT06594445 .
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE ® NK cell engager platform. Our TriKE ® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE ® technology. For more information, please visit gtbiopharma.com .
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and we undertake no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to our filings with the Securities and Exchange Commission.
TriKE ® is a registered trademark owned by GT Biopharma, Inc.
Investor Relations Contact:
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
212-915-2577
FAQ**
What specific metrics will GT Biopharma Inc. GTBP use to assess clinical activity and pharmacodynamics in the ongoing Phase 1 trial of GTB-3650?
How does GT Biopharma Inc. GTBP plan to manage risks associated with the dose escalation process in the upcoming Cohort 4 and beyond of the GTB-3650 trial?
Can you clarify how the promising immune activation levels in Cohort 3 might influence the projected timeline for subsequent cohorts and overall trial progression for GT Biopharma Inc. GTBP?
What potential implications do the recent findings on immune activation have for GT Biopharma Inc. GTBP's long-term development strategy in the competitive immuno-oncology landscape?
**MWN-AI FAQ is based on asking OpenAI questions about GT Biopharma Inc. (NASDAQ: GTBP).
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