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

NCT03018405

Description:

THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).

Related Conditions:
  • Acute Myeloid Leukemia
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Fallopian Tube Carcinoma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications
  • Official Title: A Multi-national, 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 (THINK - THerapeutic Immunotherapy With NKR-2)

Clinical Trial IDs

  • ORG STUDY ID: CYAD-N2T-002
  • NCT ID: NCT03018405

Conditions

  • Colorectal Cancer (CRC)
  • Ovarian Cancer (Epithelial and Fallopian Tube )
  • Urothelial Carcinoma
  • Triple-negative Breast Cancer (TNBC)
  • Pancreatic Cancer
  • Acute Myeloid Leukemia/Myelodysplastic Syndrome
  • Multiple Myeloma (MM)

Interventions

DrugSynonymsArms

Purpose

THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).

The trial will test three dose levels. At each dose, the patients will receive three successive administrations, two weeks apart, NKR-2 cells. The dose escalation part of the study will enroll up to 24 patients while the extension phase would enroll 86 additional patients.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Hematological tumorsExperimentalThe dose escalation arm for hematological tumors will use a 3 +3 design to determine the maximum tolerated dose.
    Solid TumorsExperimentalThe dose escalation arm for solid tumors will use a 3 +3 design to determine the maximum tolerated dose.

      Eligibility Criteria

      Inclusion Criteria:

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

      2. Patient with Colorectal cancer, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, Triple Negative Breast cancer, pancreatic cancer, AML/MDS or Multiple Myeloma

      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

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

      Exclusion Criteria:

      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 treatment

      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NKR-2 infusion
      Time Frame:24 months
      Safety Issue:
      Description:Safety defined by Occurrence of adverse events (AEs) and serious adverse events (SAEs) during the study treatment until 30 days after the last study treatment administration.

      Secondary Outcome Measures

      Measure:Clinical activity of the treatment in each tumor type
      Time Frame:24 months
      Safety Issue:
      Description:Clinical activity of the treatment in each tumor type

      Details

      Phase:Phase 1
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Celyad (formerly named Cardio3 BioSciences)

      Trial Keywords

        Last Updated

        March 8, 2017