Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT03018405
Eligibility Criteria:
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.
* Patients 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.
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).
Detailed disease specific criteria exist and can be discussed with contacts listed below.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03018405
Study Brief:
Protocol Section:
NCT03018405