GT Biopharma Advances Phase 1 Trial for Hematologic Malignancies

Author: Logan Wright Updated: 10-23-2025 09:22 AM

GT Biopharma's Promising Phase 1 Clinical Trial Update

GT Biopharma, Inc. (NASDAQ: GTBP) has exciting news to share regarding its Phase 1 trial of GTB-3650, a treatment aimed at patients with relapsed or refractory hematologic malignancies expressing CD33. The recent completion of the Cohort 3 safety review has paved the way for the next phase of the trial, moving forward with the Cohort 4 dosing regimen. The increase to a dose of 10 ug/kg/day follows a thorough analysis showing no significant safety or tolerability concerns in previous cohorts.

Pioneering a New Treatment Approach

Active screening for participants in Cohort 4 is currently underway, with plans to start dosing soon. This increase in dosage is particularly noteworthy as it aligns more closely with anticipated clinical efficacy, especially considering the encouraging trends observed with immunological biomarkers during the earlier cohorts. Patients treated in Cohorts 1 through 3 have demonstrated positive responses, which signals great potential for the ongoing study.

Overview of the Phase 1 Trial Design

The clinical trial aims to involve around 14 patients, with each cohort consisting of two individuals. The study's structure includes a wide range of dosages from a cautious initial 1.25 ug/kg/day up to 100 ug/kg/day for those in the upper cohorts. This innovative approach not only assesses the effectiveness of GTB-3650 in combating synaptic connections of hematologic malignancies but also explores the safety, pharmacokinetics, and the expansion of the body’s natural killer (NK) cells. The treatment cycles are meticulously designed, allowing for two weeks of administration followed by a two-week break, ensuring a thorough evaluation of the drug's efficacy and tolerability.

Future Updates and Expectations

Looking ahead, GT Biopharma plans to provide further updates on the trial in the first quarter of the following year. The company is committed to rigorously assessing safety and effectiveness as it continues to explore dosage levels as high as 100 ug/kg/day across additional cohorts, should the data support such an escalation. This proactive approach is indicative of the company's dedication to advancing novel cancer therapies.

About GT Biopharma, Inc.

GT Biopharma is at the forefront of immunotherapy, focusing on the development of groundbreaking treatments based on their proprietary TriKE® NK cell engager technology. This platform harnesses and amplifies the natural cancer-fighting abilities of a patient's immune system. With exclusive licensing rights from the University of Minnesota, GT Biopharma is poised to lead advancements in the field of immuno-oncology, aiming to bring innovative therapeutic products to market.

Frequently Asked Questions

What is the focus of GT Biopharma’s Phase 1 trial?

The trial focuses on evaluating GTB-3650 as a potential treatment for relapsed or refractory hematologic malignancies expressing CD33.

What was the outcome of the Cohort 3 safety review?

Cohort 3's safety review showed no identifiable safety or tolerability issues, allowing advancement to Cohort 4.

How many patients does the trial aim to involve?

The trial aims to involve approximately 14 patients across various cohorts with differing dosages.

When can we expect the next update from GT Biopharma?

The next update regarding the trial is anticipated in the first quarter of the following year.

What is the TriKE® platform technology?

The TriKE® platform is designed to enhance the immune system's natural killer cells to fight cancer more effectively.

About The Author

Dedicated Author and financial expert Logan Wright here, 29 years old. After earning an economics degree, I spent a number of years working in different financial industries. My great passion is enabling everyone, from any background or experience level, to understand and be literate in financial matters.

My books and writings are centered on simplifying difficult financial ideas into doable, understandable guidance. Whether it's retirement planning, investing, or budgeting, I want to arm readers with the information they need to make wise financial choices and realize their financial objectives.

Apart from writing, I also frequently post to financial blogs and organize webinars and workshops targeted at enlightening participants about personal finance. Always, my strategy is to offer concise, doable advice that can truly improve people's lives.

Away from work, I like to read, travel, and sample new foods. My goal is to infuse everything I do with the balance that I think is essential to both financial and personal well-being. By my profession, I want to encourage and enable people to confidently and clearly take charge of their financial futures.

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