{"status":"OK","data":{"advertisement":{"id":241035,"title":"ZAPYTANIE OFERTOWE Nr 1/FENG-HAN/2024","partial_offer_allowed":false,"publication_date":"2024-01-05","submission_deadline":"2024-02-07 00:00:00","planned_sign_date":null,"supplementary_orders":null,"terms_of_contract_change":"Wszelkie zmiany w umowie, kt\u00f3ra zostanie zawarta w wyniku post\u0119powania, wymagaj\u0105 formy pisemnej, pod rygorem niewa\u017cno\u015bci.","created_at":"2024-01-05 12:00:59","modified_at":"2024-01-05 12:43:42","contact_persons":[{"id":3621,"forename":"Ma\u0142gorzata","surname":"S\u0119ktas","phone_number":"+48 22 5936277","email":"m.sektas@cellis.eu","created_by":null,"created_at":"2026-03-20 13:48:06","modified_at":"2026-03-20 13:48:06","modified_by":null}],"orders":[{"id":391117,"estimated_value":null,"order_items":[{"id":441090,"description":"Badanie kliniczne I fazy - procedury szpitalne. Planowana data rozpocz\u0119cia realizacji zam\u00f3wienia: 01.01.2027 r.\n\n2.2 Na wy\u017cej wymienione zam\u00f3wienie sk\u0142ada si\u0119:\nWykonywanie procedur szpitalnych u pacjent\u00f3w z rakiem g\u0142owy i szyi, z chorob\u0105 przetrwa\u0142\u0105 lub progresj\u0105 miejscow\u0105 po leczeniu chemioradioterapi\u0105 lub radioterapi\u0105 radykaln\u0105 bez obecno\u015bci odleg\u0142ych przerzut\u00f3w, zrekrutowanych do badania klinicznego fazy I, w tym:\n1) Podanie preparatu kom\u00f3rkowego doguzowo,\n2) Zarz\u0105dzenie pacjentami (\u0142\u0105cznie 12 pacjent\u00f3w: 4 grupy dawkowania po 3 pacjent\u00f3w):\na) min. 7 wizyt pacjent\u00f3w (badanie przesiewowe, 1 aplikacja preparatu kom\u00f3rkowego, + 4 dni, 2 aplikacja preparatu kom\u00f3rkowego, +4 tygodnie, +12 tygodni, +24 tygodnie) \u2013 wykonywanie bada\u0144 przedmiotowych, podmiotowych, bada\u0144 obrazowych, bada\u0144 laboratoryjnych,\nb) maks. 4 aplikacje preparatu kom\u00f3rkowego (w maks. 7 dniowych odst\u0119pach),\nc) 6-miesi\u0119czny okres obserwacji prze\u017cycia wolnego od progresji,\nd) 12-miesi\u0119czna obserwacja ca\u0142kowitego czasu prze\u017cycia,\n\n3) Ocena guza po 4 dniach, nast\u0119pnie 4 tygodniach, 3 miesi\u0105cach (12 tygodni), 6 miesi\u0105cach (24 tygodnie) po rozpocz\u0119ciu leczenia pacjenta,\n4) Potwierdzenie pierwszej progresji za pomoc\u0105 kontrolnych bada\u0144 obrazowych (MRI) po co najmniej trzech miesi\u0105cach od pierwszego badania dokumentuj\u0105cego progresj\u0119 choroby (PD, ang. progessive disease),\n\nWyj\u0105tek: je\u015bli badacz zdecyduje si\u0119 rozpocz\u0105\u0107 alternatywne interwencje terapeutyczne.\n\nW okresie potwierdzenia leczenie mo\u017ce by\u0107 kontynuowane zgodnie z planem, je\u015bli pacjent, zgodnie z ocen\u0105 badacza, odnosi widoczne korzy\u015bci kliniczne przy minimalnej i akceptowalnej toksyczno\u015bci.\n\n5) Przeprowadzenie oceny guza,\n6) Przeprowadzenie oceny przep\u0142ywu krwi w obr\u0119bie guza,\n7) Kwalifikacja odpowiedzi guza zostanie jako odpowied\u017a ca\u0142kowita (CR, ang. complete response), odpowied\u017a cz\u0119\u015bciowa (PR, ang. partial response), choroba stabilna (SD, ang. stable disease) lub choroba post\u0119puj\u0105ca (PD), \n8) Monitorowanie prze\u017cycia dla ka\u017cdego pacjenta a\u017c do \u015bmierci lub przez co najmniej 12 miesi\u0119cy.\n\nBadanie kliniczne b\u0119dzie monitorowane przez zewn\u0119trzn\u0105 firm\u0119 CRO (Contract Research Organization).\n\nG\u0142\u00f3wnym celem badania jest ocena bezpiecze\u0144stwa podania preparatu kom\u00f3rkowego u pacjent\u00f3w oraz ustalenie dawki zalecanej (RD, ang. recommended dose) dla fazy II, bior\u0105c pod uwag\u0119 g\u0142\u00f3wny punkt ko\u0144cowy: Wyst\u0119powanie toksyczno\u015bci limituj\u0105cej dawk\u0119 (DLT, ang. dose limiting toxicities).\n\nOstateczny zakres zapytania ofertowego b\u0119dzie uzale\u017cniony od rozwoju projektu \ni b\u0119dzie wynika\u0142 z aktualnych potrzeb Zamawiaj\u0105cego. \nZamawiaj\u0105cy zastrzega sobie mo\u017cliwo\u015b\u0107 realizacji zam\u00f3wienia w jakiejkolwiek cz\u0119\u015bci, \na Wykonawcy nie przys\u0142uguj\u0105 z tego tytu\u0142u \u017cadne roszczenia.\n\nPhase I of clinical trials - hospital procedures.\n\nPlanned date of starting of the order: January 01, 2027.\n\n2.2\tThe above-mentioned order consist of:\nPerforming hospital procedures in patients with head and neck cancer, with persistent disease or local progression after treatment with chemoradiotherapy or radical radiotherapy without the presence of distant metastases, recruited for a phase I clinical trial, including:\n1)\tIntratumor administration of the cellular preparation,\n2)\tPatient management (12 patients in total: 4 dose groups of 3 patients each):\na)\tmin. 7 patient visits (screening test, 1st application of a cell preparation, +4 days,\n2nd application of cell preparation, +4 weeks, +12 weeks, +24 weeks) \u2013 performing physical and 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Stable Disease (SD) \nor Progressive Disease (PD),\n8)\tPerforming survival update monitoring for each patient until death or for a minimum of 12 months.\n\n\nThe clinical trial will be monitored by an external CRO company (Contract Research Organization).\n\nThe main aim of the study is to assess the safety of local administration of a cellular preparation \nin patients and to establish the recommended dose (RD) for phase II, taking into account the main endpoint: Occurrence of dose-limiting toxicity (DLT).\n\nThe final scope of the request for quotation will depend on the development of the project \nand will result from the current needs of the Ordering Party. \nThe Ordering Party reserves the right to complete the order in any part, \nand the Contractor is not entitled to any claims in this respect.\n","warranty_period":null,"cpv_items":[{"id":8513,"code":"73100000-3","name":"Us\u0142ugi badawcze i 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