GT Biopharma Receives FDA Clearance for Phase I Clinical Trial

GT Biopharma Receives FDA Clearance for Phase I Clinical Trial

Elara Kostas
2 min read

GT Biopharma Receives FDA Clearance for GTB-3650 Clinical Trial

GT Biopharma has been given the green light by the FDA to initiate a Phase I clinical trial for GTB-3650, a targeted treatment for CD33+ leukemia. The trial, scheduled to commence in the latter half of 2024, will enroll adult patients with relapsed or refractory CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Participants will receive treatment in two-week cycles over a maximum of four months, subject to clinical outcomes. The primary objective of the study is to evaluate the drug's safety, pharmacokinetics, pharmacodynamics, and its potential to expand endogenous NK cells. In addition, GT Biopharma has outlined plans to submit an IND application for GTB-5550 TriKE, targeting B7H3 positive solid tumors, with expectations for a Phase I trial in 2025. The company is confident that its existing financial resources will sustain operations through 2025. Michael Breen, Executive Chairman and Interim CEO, highlighted the potential of GTB-3650 in enhancing NK cell activity, with the aim of improving outcomes compared to traditional AML chemotherapies.

Key Takeaways

  • FDA grants clearance for GT Biopharma's Phase I trial targeting CD33+ leukemia.
  • Trial commencement slated for H2 2024, focusing on evaluating GTB-3650 in adult CD33+ leukemia patients.
  • Study subjects encompass individuals with relapsed or refractory hematologic malignancies.
  • Emphasis on investigating the safety, pharmacokinetics, and clinical activity of GTB-3650.
  • GT Biopharma's intent to file an IND for GTB-5550, targeting B7H3 positive solid tumors, in Q1 2025.


GT Biopharma's authorization from the FDA for the GTB-3650 trial enhances its position in the field of oncology, potentially impacting key players such as Celgene and Novartis. In the short term, it is anticipated that GT Biopharma's stock may experience an upturn, attracting investor attention and potentially stimulating new partnerships. Over the long term, successful trials could redefine the treatment landscape for CD33+ leukemia, optimizing NK cell therapies over traditional chemotherapies and expanding GT Biopharma's market share. The company's strategic focus on NK cell expansion places it in a favorable position for future developments in cancer treatment.

Did You Know?

  • CD33+ Leukemia:
    • CD33 is a glycoprotein present on the surface of cells in the myeloid lineage, including cells in acute myeloid leukemia (AML).
    • CD33+ leukemia denotes leukemia types where the cancerous cells express the CD33 antigen, rendering them susceptible to specific therapies like GTB-3650.
  • Pharmacokinetics and Pharmacodynamics:
    • Pharmacokinetics pertains to the study of how the body assimilates, distributes, metabolizes, and eliminates drugs.
    • Pharmacodynamics centers on the biochemical and physiological effects of drugs on the body, encompassing their mechanisms of action and therapeutic effectiveness.
  • IND Application (Investigational New Drug):
    • An IND application comprises a submission submitted to the FDA to facilitate the commencement of clinical trials involving a new pharmaceutical substance.
    • The IND process ensures that the clinical trial protocol aligns with regulatory standards for safety and ethical considerations prior to human testing initiation.

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