相关临床试验
1
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1965
终止
1
100.0%
暂无批准数据
- GT Biopharma successfully completed safety review for Cohort 3 of its Phase 1 GTB-3650 trial, with no safety or tolerability issues observed across six patients. - The company has advanced to Cohort 4 dosing at 10μg/kg/day, which represents a potential clinical efficacy threshold based on positive immunological biomarker trends. - GTB-3650 targets relapsed or refractory blood cancers expressing CD33 protein, including acute myeloid leukemia and high-risk myelodysplastic syndrome. - The hematologic malignancies treatment market reached $72 billion in 2025 and is projected to nearly double to $139 billion by 2034.
- GT Biopharma has successfully completed dosing in the first cohort of its Phase 1 trial for GTB-3650, a second-generation TriKE immunotherapy, with no safety or tolerability issues observed. - Both patients in Cohort 1 demonstrated early biological signs of immune activation, including increased natural killer cell activity and expansion, supporting the therapy's mechanism of action. - The trial, which will evaluate approximately 14 patients across seven dose cohorts, aims to treat relapsed or refractory CD33-expressing hematologic malignancies through enhanced NK cell-mediated cancer destruction.
- GT Biopharma has secured approximately $0.7 million in gross proceeds through the exercise of existing warrants at $4.35 per share, strengthening its financial position for TriKE® platform development. - The company will issue new unregistered warrants for 604,138 shares with an exercise price of $2.02 per share, providing additional future funding potential for immuno-oncology therapeutic development. - The transaction, expected to close by February 27, 2025, includes H.C. Wainwright & Co. as exclusive placement agent, with proceeds directed towards working capital and corporate initiatives.
- GT Biopharma initiated a Phase 1 trial of GTB-3650, a second-generation TriKE, for relapsed or refractory CD33-expressing hematologic malignancies. - The trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of GTB-3650 in up to 14 patients. - GTB-3650 utilizes camelid nanobody technology to potentially improve potency and enhance binding affinity to target cells. - Initial data from the Phase 1 trial is anticipated in 2025, marking a significant milestone for GT Biopharma's clinical development.
