{"status":"OK","data":{"advertisement":{"id":242564,"title":"ZAPYTANIE OFERTOWE 1/FENG-HAN/2024","partial_offer_allowed":false,"publication_date":"2024-02-06","submission_deadline":"2024-03-06 23:59:59","planned_sign_date":null,"supplementary_orders":null,"terms_of_contract_change":"1. Zamawiaj\u0105cy zastrzega sobie prawo uniewa\u017cnienia post\u0119powania na ka\u017cdym jego etapie, bez podania przyczyn.\n2. Niniejsze zaproszenie do sk\u0142adania ofert nie zobowi\u0105zuje Zamawiaj\u0105cego do zawarcia umowy.","created_at":"2024-02-06 16:35:49","modified_at":"2024-03-07 00:00:03","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":393458,"estimated_value":null,"order_items":[{"id":443648,"description":"Nab\u00f3r FENG.01.01-IP.01-005/23 \"Innowacyjna terapia kom\u00f3rkowa raka g\u0142owy i szyi\"\n\nBadanie kliniczne I fazy - procedury szpitalne.\nPlanowana data rozpocz\u0119cia realizacji zam\u00f3wienia: 01.03.2027 r.\n\nNa 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.\nPlanned date of starting of the order: March 01, 2027.\n\nThe 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 subjective examinations, imaging tests, laboratory tests,\nb)\tmax. 4 applications of the cellular preparation (at max. 7-day intervals),\nc)\t6-month follow-up period for progression-free survival,\nd)\t12-month follow-up of overall survival,\n\n3)\tTumor assessment after 4 days, then after 4 weeks, 3 months (12 weeks), 6 months (24 weeks)\nafter study treatment starts,\n\n4)\tConfirmation of the first progression using follow-up imaging (MRI) at least three months after the first examination documenting disease progression (PD), unless the researcher decides to initiate alternative therapeutic interventions,\n\nDuring the confirmation period, treatment may continue as planned if the patient, in the investigator's judgment, demonstrates demonstrable clinical benefit with minimal and acceptable toxicity.\n\n5)\tConducting tumor assessment,\n6)\tConducting an assessment of blood flow within the tumor,\n7)\tQualifying tumor response as Complete Response (CR), PartiaI Response (PR), 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.","warranty_period":null,"cpv_items":[{"id":8513,"code":"73100000-3","name":"Us\u0142ugi badawcze i eksperymentalno-rozwojowe"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":null,"poviat":null,"commune":null,"locality":null,"created_by":null,"created_at":"2024-02-06 16:35:49","modified_at":"2024-02-06 16:35:49","modified_by":null,"id":497148,"type":{"id":2,"name":"ca\u0142a Polska"},"group_uuid":"1e806919-3b46-4e23-801a-87e4b5a07511"}],"participation_conditions":[{"id":1213703,"description":"Wykonawca musi posiada\u0107 niezb\u0119dn\u0105 wiedz\u0119 i udokumentowane do\u015bwiadczenie w wykonywaniu zabieg\u00f3w chirurgicznych u pacjent\u00f3w z nowotworami g\u0142owy i szyi z pierwsz\u0105 wznow\u0105 w ci\u0105gu ostatnich 3 lat \noraz w prowadzeniu bada\u0144 klinicznych wczesnej fazy - zw\u0142aszcza fazy I, II, First in Human - w ci\u0105gu ostatnich 3 lat.\n\nConractor must have the necessary knowledge and documented experience in performing surgical procedures in patients with head and neck cancer with first recurrence in the last 3 years and in conducting early phase clinical trials - especially phase I, II, First in Human studies - in the recent 3 years.","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2024-02-06 16:35:49","modified_at":"2024-02-06 16:35:49","modified_by":null,"group_uuid":"0e52ce0a-9417-4c5d-8238-cedf08656848"},{"id":1213704,"description":"Wykonawca musi posiada\u0107 niezb\u0119dny potencja\u0142 techniczny, w tym:\n*zasoby techniczne:\n- Zaplecze szpitalne diagnostyki obrazowej \u2013 w tym obowi\u0105zkowo rezonans magnetyczny,\n- Szpitalne zaplecze neurochirurgiczne,\n- Szpitalne zaplecze onkologiczne,\n- Szpitalne zaplecze do bada\u0144 laboratoryjnych,\n*sprz\u0119t:\n- Komora laminarna do czystej pracy do przygotowania preparatu (rozmro\u017cenia),\n- zamra\u017carka -80C,\n- Kontener na ciek\u0142y azot.\n\nContractor must have the necessary technical potential, including the appropriate:\n*technical resources:\n- hospital imaging diagnostic facilities - mandatory with magnetic resonance imaging,\n- hospital neurosurgical facilities,\n- hospital oncology facilities,\n- hospital facilities for laboratory tests,\n*equipment:\n- Laminar chamber for clean work to specimen preparation (thawing),\n- Freezer -80C,\n- Liquid nitrogen container.","type":{"id":3,"name":"Potencja\u0142 techniczny"},"created_by":null,"created_at":"2024-02-06 16:35:49","modified_at":"2024-02-06 16:35:49","modified_by":null,"group_uuid":"67dbdfd0-a5c1-4346-89ae-0b3b0ca6d4c7"},{"id":1213705,"description":"Wykonawca musi posiada\u0107 potencja\u0142 kadrowy wyspecjalizowany w co najmniej w nast\u0119puj\u0105cych dziedzinach: onkologia i chirurgia.\nContractor must have staff potential specialized in at least the following areas: oncology and surgery.","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2024-02-06 16:35:49","modified_at":"2024-02-06 16:35:49","modified_by":null,"group_uuid":"f0d67d4b-4ce3-43cf-9742-865e92ad1e63"},{"id":1213706,"description":"Wykonawca musi znajdowa\u0107 si\u0119 w sytuacji ekonomicznej i finansowej zapewniaj\u0105cej czasowe i zgodne z wymaganiami stawianymi w zapytaniu ofertowym wykonanie zam\u00f3wienia.\nContractor must be in a business and financial situation that ensure timely and requirement compliant performance of the contract.","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2024-02-06 16:35:49","modified_at":"2024-02-06 16:35:49","modified_by":null,"group_uuid":"c4b0f6f3-11e8-4586-9950-d8dbc0cb2ba0"},{"id":1213707,"description":"Wykonawca musi deklarowa\u0107 gotowo\u015b\u0107 do przestrzegania protoko\u0142u badania, a tak\u017ce najnowszej wersji Deklaracji Helsi\u0144skiej, ICH-GCP oraz krajowych warunk\u00f3w prawnych i regulacyjnych.\nContractor must declare readiness to comply with the study protocol, as well as the latest version of the Helsinki Declaration, ICH-GCP and national legal and regulatory conditions.","type":{"id":1,"name":"Uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci"},"created_by":null,"created_at":"2024-02-06 16:35:49","modified_at":"2024-02-06 16:35:49","modified_by":null,"group_uuid":"ef15a36a-05fd-47a1-9891-31520c9bace9"},{"id":1213708,"description":"1. Ka\u017cdy Oferent mo\u017ce z\u0142o\u017cy\u0107 jedn\u0105 ofert\u0119.\n2. Oferta musi by\u0107 z\u0142o\u017cona na Formularzu ofertowym (Za\u0142\u0105cznik 1 do Zapytania ofertowego 1/FENG-HAN/2024). Oferta musi by\u0107 parafowana i podpisana przez nale\u017cycie umocowanego przedstawiciela Oferenta. W przypadku podpisania oferty przez osob\u0119 niewymienion\u0105 w dokumencie rejestrowym (ewidencyjnym) Oferenta, nale\u017cy do oferty do\u0142\u0105czy\u0107 stosowne pe\u0142nomocnictwo.\n3. Oferent zobowi\u0105zany jest z\u0142o\u017cy\u0107 wraz z ofert\u0105 aktualny odpis z krajowego rejestru s\u0105dowego lub z centralnej ewidencji i informacji o dzia\u0142alno\u015bci gospodarczej, wystawiony nie wcze\u015bniej ni\u017c trzy (3) miesi\u0105ce przed up\u0142ywem terminu sk\u0142adania ofert, w celu wykazania braku podstaw do wykluczenia. \n\n1. Each Bidder may submit only one offer.\n2. Offer should be prepared in the bid form (Appendix 1 to the Request for Quotation no. 1/FENG-HAN/2024). The offer must be initialled and signed by the authorised representative of the Bidder.\nIf the offer would be signed by the person not listed in registered documents of the Contractor, the offer shall be accompanied by the appropriate power of attorney.\n3. Offer must include all attachments required by the Ordering Party confirmed to be true \nby the authorised representative of the Bidder.\n4. 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