Drugs / GTB-3550
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03214666 | Jan 2020 → Aug 2021 | acute myeloid leukemia, mast cell leukemia, myelodysplastic syndrome | GT Biopharma, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2022-04-11 | GT Biopharma, Inc. | Results GT Biopharma Presents Preclinical Data Demonstrating Novel B7H3+ Tumor Targeting GTB-5550 TriKE® Driving NK Cell Activation and ADCC Against Head and Neck Squamous Cell Carcinomas at AACR Annual Meeting 2022 gtbiopharma.com ↗
Results - NK cell degranulation and IFN-gamma production of GTB-3550-treated samples were higher compared to that of control samples treated with B7H3 single domain or IL-15 alone. |
| 2021-09-20 | GT Biopharma, Inc. | Results GT BioPharma's Next Generation Camelid TriKE® Nanobody Platform Highlighted at ESMO Congress 2021 gtbiopharma.com ↗
Patient 11 had a bi-phenotypic leukemia which co-expressed both CD19 (a lymphoid marker) and CD33 (the myeloid marker which is targeted by GTB-3550); this patient showed a 50% reduction in CD33-positive leukemic cells (blasts), evidence of anti-leukemic activity of GTB-3550. |
| 2021-09-15 | GT Biopharma, Inc. | Results GT Biopharma Announces Updated Positive Safety Data From Phase 1 GTB-3550 Monotherapy TriKE™ Trial an Investigational Immunotherapy for Refractory Cancers to be Presented at ESMO Congress 2021 gtbiopharma.com ↗
The mini-oral presentation will present updated positive Phase 1 safety data, progress, and preclinical data going beyond hematologic malignancies to solid tumors of a Phase 1 GTB-3550 TriKE trial. |
| 2021-06-23 | GT Biopharma, Inc. | Results GT Biopharma Announces Interim GTB-3550 Trike™ Monotherapy Clinical Trial Results At 2021 Raymond James Human Health Innovation Conference gtbiopharma.com ↗
In addition to strong safety results, we have seen significant reductions in CD33+ cancer cells in four of the last seven patients (57%) treated with doses of GTB-3550 ranging from 25mcg/kg/day to 150mcg/kg/day. |
| 2021-05-18 | GT Biopharma, Inc. | Results GT Biopharma to Host Interim GTB-3550 TriKE™ Data Review Call with Dr. Jeffrey S. Miller on May 19, 2021 at 4:00 PM ET gtbiopharma.com ↗
Results demonstrated up to 63.7% reduction in bone marrow blast levels, and restoration of endogenous NK cell function, proliferation and immune surveillance without combination ex vivo supplemental NK cell therapy. |
| 2021-04-12 | GT Biopharma, Inc. | Results GT Biopharma Announces GTB-3550 TriKE™ Monotherapy Rescues and Restores NK Cell Immune Surveillance in Relapsed/Refractory AML and MDS Cancer Patients gtbiopharma.com ↗
GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary NK cell engager (TriKE™) protein biologic technology platform, announced today additional interim results from its GTB-3550 TriKE™ first-in-human Phase I/II clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML). |
| 2021-03-29 | GT Biopharma, Inc. | Results GT Biopharma's TriKE™ Interim Clinical Trial Results Presented At Innate Killer Summit 2021 gtbiopharma.com ↗
Highlights of GT Biopharma's updated interim GTB-3550 TriKE™ Phase I/II clinical trial results included: |
| 2021-03-17 | GT Biopharma, Inc. | Results GT Biopharma Announces Updated Interim GTB-3550 Trike™ Clinical Trial Results gtbiopharma.com ↗
Three of the five patients (60%) experienced reduction in bone marrow blasts with two patients (one patient treated at the 50mcg/kg/day dose level and one patient treated at the 100mcg/kg/day dose level) experiencing significant reductions in bone marrow blast levels. |
| 2020-12-21 | GT Biopharma, Inc. | Results GT BIOPHARMA ANNOUNCES FDA DATA - GTB-3550 TriKE™ REDUCES CANCER CELLS BY 61.7% FOR A HIGH-RISK MYELODYSPLASTIC SYNDROMES (HR-MDS) PATIENT gtbiopharma.com ↗ |
| 2020-12-08 | GT Biopharma, Inc. | Results GT Biopharma Announces GTB-3550 TriKE(TM) Reduces Bone Marrow Blast Levels, Improves NK Cell Function and Proliferation, and No Toxicities Observed in AML and MDS Patients gtbiopharma.com ↗ |
| 2020-11-12 | GT Biopharma, Inc. | Results GT Biopharma Announces Publication of GTB-3550 TriKE Interim Results at the Prestigious 62nd American Society of Hematology (ASH) Annual Meeting gtbiopharma.com ↗
GTB-3550 TriKE™ for the Treatment of High-Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML) Safely Drives Natural Killer (NK) Cell Proliferation At Initial Dose Cohorts |
| 2020-09-22 | GT Biopharma, Inc. | Results GT Biopharma Announces GTB-3550 TriKE(TM) Phase I/II Clinical Trial Update gtbiopharma.com ↗
The first patient treated with GTB-3550 at a 25mcg/kg/day dose showed a decrease in AML blast levels from 18% to 12% in the bone marrow. |
| 2020-08-04 | GT Biopharma, Inc. | Results GT Biopharma Advances To Dose Level 3 with TriKE(TM) FDA Phase I/II Clinical Trial gtbiopharma.com ↗
Following initial treatment, the first patient treated with GTB-3550 achieved stable disease with respect to the number of acute myeloid leukemia (AML) blasts observed in their bone marrow before and after treatment. |
| 2020-03-31 | GT Biopharma, Inc. | Results GT Biopharma Announces Commencement of Retreatment of Patient Demonstrating Successful Clinical Benefit following GTB-3550 TriKE(TM) therapy gtbiopharma.com ↗
Following initial treatment, the patient achieved stable disease with respect to the number of AML blasts observed in their bone marrow before and after and showed no adverse events (side effects). |
| 2020-03-19 | GT Biopharma, Inc. | Results UPDATE: GT Biopharma Announces Preliminary Results for GTB-3550 TriKE(TM) Phase I/II Clinical Trial for Treatment of Acute Myeloid Leukemia gtbiopharma.com ↗
There were no observed adverse or serious adverse events recorded during the course of therapy, and the patient achieved stable disease as measured by AML blast count. |
| 2020-03-19 | GT Biopharma, Inc. | Results GT Biopharma Announces Preliminary Results for GTB-3550 TriKE(TM) Phase I/II Clinical Trial for Treatment of Acute Myeloid Leukemia gtbiopharma.com ↗
There were no observed adverse or serious adverse events recorded during the course of therapy, and the patient achieved stable disease as measured by AML blast count. |
| 2018-11-01 | GT Biopharma, Inc. | Regulatory GT Biopharma Receives FDA Clearance to Commence First-in-Human Phase 1 Study of its First-in-Class Tri-Specific Killer Engager (TriKE), GTB-3550, for the Treatment of Acute Myelogenous Leukemia, Myelodysplatic Syndrome and Mastocytosis gtbiopharma.com ↗ |
All press releases naming this drug 26 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GTB-3550 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03214666 ↗ |
| Modality | Other / unclassified | “tri-specific killer cell engager (TriKE®)” NCT03214666 ↗ |