A multinational, open-label, dose escalation Phase I/II study to assess the safety and clinical activity of multiple administrations of NKR-2 in patients with different metastatic tumor types - THerapeutic Immunotherapy with NKR-2 (THINK)

Celyad SA0 个研究点目标入组 122 人开始时间: 2016年9月8日最近更新: 2017年1月16日

试验速览

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•Main inclusion criteria are:
•1) Men or women = 18 years old at the time of signing the ICF, 2) Patient with a CRC, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, TNBC, pancreatic cancer, AML/MDS or MM, 3) Disease must be measurable according to the corresponding guidelines, 4) Patient with an ECOG performance status 0 or 1, 5) Patient with adequate bone marrow reserve, hepatic and renal functions.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 111
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 11

•Main exclusion criteria are: 1) Patient with a tumor metastasis in the central nervous system,
•2) Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis, 3) 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, 4) Patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent, 5) Patients who have received other cell therapies, 6) Patients who underwent major surgery within 4 weeks before the planned day for the first NKR-2 administration.

发起方

Celyad SA