Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie 12203 Berlin (Berlin) GermanyRekrutierend» Google-MapsBrustzentrum am Universitätsklinikum Hamburg-Eppendorf Martinistraße 52 20251 Hamburg DeutschlandRekrutierend» Google-MapsUniversity of Miami Hospital and Clinics 33136 Miami United StatesRekrutierend» Google-Maps Ansprechpartner:
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1. Evaluate safety and tolerability of treatment with treatment with ACTengine® IMA203/IMA203CD8 products as monotherapy or in combination with nivolumab (Time Frame - 35 days): Treatment emergent adverse events
2. Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 (Time Frame - 28 days): Number of patients with dose-limiting toxicities (DLTs)
Secondary outcome:
1. Persistence of T-cells (Time Frame - up to 5 years post treatment): Measurement of TCR-engineered T cells in peripheral blood
2. Tumor response (Time Frame - up to 12 months): Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
3. Tumor response (Time Frame - up to 12 months): Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST)
IMA203 Product: The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
IMA203CD8 Product: The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
IMADetect®: IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials. IMADetect® is intended for investigational use only.
nivolumab (Opdivo®) (Opdivo®): Nivolumab will be given post IMA203 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors"
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