Last updated on December 2018

A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Colorectal Cancer | Ovarian Cancer | Triple Negative Breast Cancer | Multiple Myeloma | Pancreatic Cancer | Transitional cell carcinoma | Acute Myeloid Leukemia/Myelodysplastic Syndrome
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Men or women 18 years old at the time of signing the ICF
  2. Pati 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.

Detailed disease specific criteria exist and can be discussed with contacts listed below.

Exclusion Criteria:

  1. 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).

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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