GT Biopharma Advances into Cohort 3 of GTB-3650 Phase 1 Trial Following Safety Review of Cohort 2
GT Biopharma (NASDAQ: GTBP) has advanced to Cohort 3 in its Phase 1 clinical trial of GTB-3650, following successful safety reviews of Cohorts 1 and 2. GTB-3650, a second-generation TriKE® natural killer cell engager, is being evaluated for treating relapsed/refractory CD33-expressing hematologic malignancies.
The trial's first four patients have shown encouraging early results, demonstrating GTB-3650's ability to activate and expand NK cells, with multiple blood biomarker assays indicating heightened immune activity. The study plans to enroll up to 14 patients across seven cohorts, with dosing in two-week cycles for up to four months. Initial Phase 1 results are expected later in 2025.
GT Biopharma (NASDAQ: GTBP) è passata al coorte 3 nella sperimentazione di Fase 1 di GTB-3650, dopo revisioni di sicurezza favorevoli delle coorti 1 e 2. GTB-3650, un TriKE® di seconda generazione che attiva le cellule natural killer, è valutato per il trattamento di neoplasie ematologiche CD33-positive recidivanti o refrattarie.
I primi quattro pazienti dello studio hanno mostrato risultati precoci incoraggianti, dimostrando la capacità di GTB-3650 di attivare ed espandere le NK, con numerosi test su biomarcatori ematici che indicano un aumento dell'attività immunitaria. Lo studio prevede di arruolare fino a 14 pazienti distribuiti in sette coorti, con somministrazioni in cicli di due settimane per un massimo di quattro mesi. I primi risultati della Fase 1 sono attesi più avanti nel 2025.
GT Biopharma (NASDAQ: GTBP) ha avanzado a la cohorte 3 en su ensayo de fase 1 de GTB-3650, tras revisiones de seguridad favorables de las cohortes 1 y 2. GTB-3650, un TriKE® de segunda generación que activa células NK, se está evaluando para el tratamiento de malignidades hematológicas con expresión de CD33 en recaída o refractarias.
Los primeros cuatro pacientes del ensayo han mostrado resultados preliminares alentadores, demostrando la capacidad de GTB-3650 para activar y expandir las células NK, con múltiples ensayos de biomarcadores sanguíneos que indican una mayor actividad inmunitaria. El estudio planea reclutar hasta 14 pacientes repartidos en siete cohortes, con administración en ciclos de dos semanas durante un máximo de cuatro meses. Se esperan los primeros resultados de fase 1 a finales de 2025.
GT Biopharma (NASDAQ: GTBP)는 코호트 1·2의 안전성 검토를 성공적으로 마치고 GTB-3650의 1상 임상에서 3차 코호트로 진입했습니다. GTB-3650은 2세대 TriKE® 자연살해(NK) 세포 작동제로, CD33을 발현하는 재발/불응성 혈액계 악성종양 치료를 위해 평가되고 있습니다.
임상 첫 4명의 환자에서 초기 유망한 결과가 관찰되어 GTB-3650이 NK 세포를 활성화하고 증식시키는 능력이 입증되었으며, 여러 혈액 바이오마커 검사에서 면역 활동 증가가 확인되었습니다. 본 연구는 7개 코호트에서 최대 14명을 모집할 예정이며 투약은 2주 간격의 사이클로 최대 4개월까지 진행됩니다. 1상 초기 결과는 2025년 후반에 발표될 예정입니다.
GT Biopharma (NASDAQ: GTBP) est passée en cohorte 3 de son essai de phase 1 de GTB‑3650, après des revues de sécurité favorables pour les cohortes 1 et 2. GTB‑3650, un TriKE® de seconde génération mobilisant les cellules NK, est évalué pour le traitement des hémopathies CD33‑positives en rechute ou réfractaires.
Les quatre premiers patients ont présenté des résultats précoces encourageants, montrant la capacité de GTB‑3650 à activer et à étendre les cellules NK, plusieurs dosages de biomarqueurs sanguins signalant une activité immunitaire accrue. L'étude prévoit d'inclure jusqu'à 14 patients répartis en sept cohortes, avec des administrations en cycles de deux semaines pendant quatre mois au maximum. Les premiers résultats de la phase 1 sont attendus plus tard en 2025.
GT Biopharma (NASDAQ: GTBP) ist nach positiven Sicherheitsprüfungen der Kohorten 1 und 2 in Kohorte 3 ihrer Phase‑1‑Studie mit GTB‑3650 vorgerückt. GTB‑3650, ein TriKE® der zweiten Generation zur Aktivierung natürlicher Killerzellen, wird zur Behandlung CD33‑positiver, rezidivierender/therapierefraktärer hämatologischer Malignome geprüft.
Die ersten vier Patienten zeigten erfreuliche erste Befunde, die die Fähigkeit von GTB‑3650 zur Aktivierung und Expansion von NK‑Zellen belegen; mehrere Blut‑Biomarker‑Assays deuteten auf eine erhöhte Immunaktivität hin. Geplant ist die Einschreibung von bis zu 14 Patienten in sieben Kohorten, mit Verabreichung in zweiwöchigen Zyklen über einen Zeitraum von bis zu vier Monaten. Erste Ergebnisse der Phase 1 werden für Ende 2025 erwartet.
- No safety or tolerability issues observed in Cohorts 1 and 2
- Early results show successful NK cell activation and expansion
- Blood biomarker assays indicate heightened immune activity
- Trial progressing as planned with advancement to Cohort 3
- None.
Insights
GT Biopharma's Phase 1 trial advances to Cohort 3 with positive safety data and encouraging biomarker results from initial patients.
GT Biopharma has made significant progress with its GTB-3650 Phase 1 dose escalation trial, successfully completing two cohorts and advancing to the third. This represents a critical early milestone for their TriKE® platform technology which is designed to engage natural killer (NK) cells against CD33-expressing blood cancers.
The safety profile observed so far is particularly noteworthy - with no safety or tolerability issues reported across the first two cohorts. This clean safety signal is crucial for novel immunotherapy approaches, as many competing platforms often struggle with cytokine release syndrome or neurotoxicity.
The early biomarker data provides preliminary validation of the mechanism of action, showing GTB-3650's ability to activate endogenous NK cells and induce their expansion. Multiple blood biomarker assays from the first four patients demonstrate heightened immune activity, suggesting the therapy is working as designed to engage the innate immune system.
The trial design includes seven potential cohorts with approximately 14 patients total, using an intermittent dosing schedule (two weeks on, two weeks off) for up to four months. This approach allows for recovery periods between treatments while maximizing potential efficacy.
While these early results are promising, it's important to note that efficacy data and complete response information are not yet available. The company plans to release more comprehensive Phase 1 results later in 2025 after completing additional dose cohorts, which will provide greater insight into the therapeutic potential of this novel immunotherapy approach.
The first patient in Cohort 3, the fifth patient in the trial, has completed the first week of cycle 1 following the successful safety review of Cohort 2 with no safety or tolerability issues observed
The company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts
SAN FRANCISCO, CALIFORNIA, Aug. 11, 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 initiation of dosing in Cohort 3 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
The Phase 1 dose escalation trial is evaluating GTB-3650, GT Biopharma’s second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies. Cohorts 1 and 2 have now both been successfully completed and following the formal safety reviews, no safety or tolerability issues have been observed. This has allowed initiation of dosing in Cohort 3, with the first patient now having completed the first week of cycle 1.
Patients from Cohort 1 and Cohort 2 have shown encouraging early results indicative of GTB-3650’s ability to activate endogenous NK cells and induce NK cell expansion. Data from multiple blood biomarker assays from the first four patients show heightened immune activity. GT Biopharma plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts.
The trial plans to evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) and 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.
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TriKE® is a registered trademark owned by GT Biopharma, Inc.
Investor Relations Contact:
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