THINK
Généralités
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
- Âge
- Seulement les adultes
- Phase de l’étude
- Phase 1/2
- Lors du diagnostic
-
- AML
- Myélome multiple
- Cancer colorectal
- Cancer du pancréas
- Cancer de la vessie
- Tumeur maligne des trompes
- Le cancer du sein triple négatif
- Cancer de l’ovaire
- Hôpitaux participants
-
-
Cliniques Universitaires Saint-Luc
-
Institut Jules Bordet
-
Critères d’inclusion: Vous pouvez participer si
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
Critères d’exclusion: Vous ne pouvez pas participer si
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).
-
Cliniques Universitaires Saint-Luc
-
Institut Jules Bordet
-
UZ Gent
Mon aperçu
Vous trouverez ici un aperçu des études que vous avez enregistrées. De cette façon, vous pouvez facilement faire une liste des études qui vous concernent. Vous pouvez également choisir d'imprimer un résumé de toutes vos études sélectionnées en une seule fois.