{"status":"OK","data":{"advertisement":{"id":241088,"title":"ZAPYTANIE OFERTOWE Nr 4/FENG-PAN/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\n\nAll modification to the agreement, which will be concluded as a result of the proceeding, must be in writing under pain of nullity","created_at":"2024-01-05 22:36:51","modified_at":"2024-01-05 22:40:36","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":391176,"estimated_value":null,"order_items":[{"id":441155,"description":"Badanie kliniczne I fazy - procedury szpitalne.\n\nPlanowana data rozpocz\u0119cia realizacji zam\u00f3wienia: 1.01.2027 r.\n\nNa wy\u017cej wymienione zam\u00f3wienie sk\u0142ada si\u0119:\nWykonywanie procedur szpitalnych u pacjent\u00f3w PDAC ze wznow\u0105 po I linii leczenia FOLFIRINOX (5-Fluorouracyl/Leukoworyna/Oksaliplatyna/Irynotekan) bez przerzut\u00f3w do m\u00f3zgu, zrekrutowanych do badania klinicznego fazy I, w tym:\n1) Podanie preparatu (MDC-PAN) dootrzewnowo lub doguzowo przez cewnik dootrzewnowy (np. Brauna, Celsite Drainaport) w po\u0142\u0105czeniu podaniem gemcytabiny do\u017cylnie,\n2) Opieka i realizacja leczenia pacjent\u00f3w (\u0142\u0105cznie 12 pacjent\u00f3w: 4 grupy dawkowania po 3 pacjent\u00f3w):\na) min. 7 wizyt pacjent\u00f3w (badanie screeningowe, 1 aplikacja preparatu kom\u00f3rkowego + gemcytabina do\u017cylnie, + 4 dni, 2 aplikacja preparatu kom\u00f3rkowego + gemcytabina do\u017cylnie, +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 + gemcytabina do\u017cylnie (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,\n3) Ocena guza po 4 dniach, nast\u0119pnie 4 tygodniach, 3 miesi\u0105cach (12 tygodni), 6 miesi\u0105cach (24 tygodniach) po rozpocz\u0119ciu leczenia pacjenta, \n4) Potwierdzenie pierwszej progresji za pomoc\u0105 kontrolnych bada\u0144 obrazowych (rezonans magnetyczny) 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 wed\u0142ug kryteri\u00f3w RECIST w. 1.1. lub iRECIST,\n6) Przeprowadzenie oceny przep\u0142ywu krwi w obr\u0119bie guza za pomoc\u0105 angio-TK,\n7) Kwalifikacja odpowiedzi guza 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 Organisation).\n\nG\u0142\u00f3wnym celem badania jest ocena bezpiecze\u0144stwa podania preparatu kom\u00f3rkowego u pacjent\u00f3w \noraz 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\nThe subject of the order is:\nPhase I of clinical trials - hospital procedures.\n\nPlanned date of starting of the order: January 01, 2027.\n\nThe above-mentioned order consist of:\nPerforming hospital procedures in PDAC patients with recurrence after first-line treatment with FOLFIRINOX (5-Fluorouracil/Leucovorin/Oxaliplatin/Irinotecan) without brain metastases recruited for a phase I clinical trial, including:\n1) Intraperitoneal or intratumoral administration (MDC-PAN) via an intraperitoneal catheter (e.g. Braun, Celsite Drainaport) in combination with intravenous gemcitabine,\n2) Care and delivery of patient treatment (12 patients in total: 4 dose groups of 3 patients each):\na) minimum 7 patient visits (screening test, 1 application of the cell drug product + gemcitabine intravenously, +4 days, 2nd application of the cell drug product + gemcitabine intravenously, +4 weeks, +12 weeks, +24 weeks) \u2013 performing physical and subjective examinations, imaging tests, laboratory tests,\nb) maksimum 4 applications of the cell drug product + gemcitabine intravenously (in max. 7 day intervals),\nc) 6-month follow-up period for progression-free survival,\nd) 12-month follow-up of overall survival,\n3) Tumor assessment at 4 days, 4 weeks, 3 months (12 weeks), 6 months (24 weeks) after study treatment starts,\n4) Confirmation of the first progression using follow-up imaging (MRI) at least three months after the first examination documenting progressive disease (PD) unless the researcher selects 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) Assessing tumor evaluation according to RECIST w. 1.1. or iRECIST criteria,\n6) Assessing blood flow within the tumor using angio-TK,\n7) Qualifying tumor response as Complete Response (CR), PartiaI Response (PR), Stable Disease (SD) \nor Progressive Disease (PD),\n8) Performing 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 the cell drug product \nin patients with glioma during the first recurrence and to establish the recommended dose (RD) \nfor phase II, considering the main endpoint: Occurrence of dose-limiting toxicity (DLT).\n\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\n","warranty_period":null,"cpv_items":[{"id":8513,"code":"73100000-3","name":"Us\u0142ugi badawcze i 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stawianymi w zapytaniu ofertowym wykonanie zam\u00f3wienia\n\nContractors 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":"2024-01-05 22:36:51","modified_at":"2024-01-05 22:40:26","modified_by":null,"group_uuid":"129c3a88-caab-40f4-99be-d3cbb9570466"},{"id":1206669,"description":"Wykonawca musi zadeklarowa\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\n\nContractors 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":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2024-01-05 22:36:51","modified_at":"2024-01-05 22:40:26","modified_by":null,"group_uuid":"39a46689-6a5c-4c0d-9621-071840b10964"},{"id":1206670,"description":"Wykonawca nie mo\u017ce by\u0107 powi\u0105zany osobowo lub kapita\u0142owo z Zamawiaj\u0105cym.\nPrzez powi\u0105zania kapita\u0142owe lub osobowe rozumie si\u0119 wzajemne powi\u0105zania mi\u0119dzy beneficjentem \nlub osobami upowa\u017cnionymi do zaci\u0105gania zobowi\u0105za\u0144 w imieniu beneficjenta lub osobami wykonuj\u0105cymi w imieniu beneficjenta czynno\u015bci zwi\u0105zane z przeprowadzeniem procedury wyboru wykonawcy a wykonawc\u0105, polegaj\u0105ce w szczeg\u00f3lno\u015bci na:\na)\tuczestniczeniu w sp\u00f3\u0142ce jako wsp\u00f3lnik sp\u00f3\u0142ki cywilnej lub sp\u00f3\u0142ki osobowej,\nb)\tposiadaniu co najmniej 10% udzia\u0142\u00f3w lub akcji, o ile ni\u017cszy pr\u00f3g nie wynika z przepis\u00f3w prawa,\nc)\tpe\u0142nieniu funkcji cz\u0142onka organu nadzorczego lub zarz\u0105dzaj\u0105cego, prokurenta, pe\u0142nomocnika,\nd)\tpozostawaniu w zwi\u0105zku ma\u0142\u017ce\u0144skim, w stosunku pokrewie\u0144stwa lub powinowactwa w linii prostej, pokrewie\u0144stwa drugiego stopnia lub powinowactwa drugiego stopnia w linii bocznej \nlub w stosunku przysposobienia, opieki lub kurateli albo pozostawaniu we wsp\u00f3lnym po\u017cyciu \nz wykonawc\u0105, jego zast\u0119pc\u0105 prawnym lub cz\u0142onkami organ\u00f3w zarz\u0105dzaj\u0105cych lub organ\u00f3w nadzorczych wykonawc\u00f3w ubiegaj\u0105cych si\u0119 o udzielenie zam\u00f3wienia,\ne)\tpozostawaniu z wykonawc\u0105 w takim stosunku prawnym lub faktycznym, \u017ce istnieje uzasadniona w\u0105tpliwo\u015b\u0107 co do ich bezstronno\u015bci lub niezale\u017cno\u015bci w zwi\u0105zku z post\u0119powaniem o udzielenie zam\u00f3wienia\n\nThe Contractor may not be personally, or equity related to the Ordering Party.\nEquity or personal relationship is understood as relations between the Ordering Party or individuals authorized to take commitments on behalf of the Ordering Party or those acting on behalf of the Ordering Party in order to prepare and implement the contract award procedure, and the Contractor, including in particular:\na)\tBeing a partner to civil law partnership or commercial law partnership,\nb)\tHolding at least 10% of shares, if lower threshold does not result from law,\nc)\tBeing a member of a supervisory or management corporate body, a holder of general commercial power of attorney, an authorised representative,\nd)\tBeing married to, being in direct consanguinity or affinity, second degree consanguinity or affinity \nof the second degree collaterally or by adoption or guardianship or being in cohabitation with the Contractor, its legal representative or members of management or supervisory bodies of economic operators competing for the contract award,\ne)\tbeing in such a legal or factual relationship with the Contractor that there is a reasonable doubt as to their impartiality or independence in connection with the contract award 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