THINK
Algemeen
A multinational, open-label, dose escalation Phase I study to assess the safety and clinical activity of multiple administrations of NKR-2 in patients with different metastatic tumor types
- Leeftijd
- Enkel volwassenen
- Fase onderzoek
- Fase 1/2
- Bij diagnose
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- AML
- Multipel myeloom
- Colorectale kanker
- Pancreaskanker
- Blaaskanker
- Eileiderkanker
- Borstkanker triple negatief
- Ovariumkanker
- Deelnemende ziekenhuizen
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Cliniques Universitaires Saint-Luc
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Institut Jules Bordet
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Inclusiecriteria: U mag meedoen als
Main inclusion criteria are:
- Men or women ≥ 18 years old at the time of signing the ICF,
- Patient with a CRC, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, TNBC, pancreatic cancer, AML/MDS or MM,
- Disease must be measurable according to the corresponding guidelines,
- Patient with an ECOG performance status 0 or 1, and AML patients with anemia resulting in an ECOG performance status of 2,
- Patient with adequate bone marrow reserve, hepatic and renal functions.
-Patient must have sufficient pulmonary functions with a Forced Expiratory Volume in the first second (FEV-1)/Forced Vital Capacity (FVC) ≥ 0.7 with FEV-1 ≥ 50% predicted
Exclusiecriteria: U mag niet meedoen als
Main exclusion criteria are:
- Patient with a tumor metastasis in the central nervous system,
- Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis (except hydroxyurea for AML patients),
- Patients who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first NKR-2 administration (except hydroxyurea for AML patients),
- Patient is under systemic immunosuppressive drugs, unless specific cases authorized per protocol.
- Patients who have received other cell therapies,
- Patients who underwent major surgery within 4 weeks before the planned day for the first NKR-2 administration.
- Patient cannot present with history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute exacerbation of chronic obstructive pulmonary disease (COPD).
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Cliniques Universitaires Saint-Luc
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Institut Jules Bordet
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UZ Gent
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