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Trial record 1 of 1 for:    NCT03018405
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A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications (THINK)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Celyad (formerly named Cardio3 BioSciences)
Sponsor:
Information provided by (Responsible Party):
Celyad (formerly named Cardio3 BioSciences)
ClinicalTrials.gov Identifier:
NCT03018405
First received: January 10, 2017
Last updated: May 18, 2017
Last verified: May 2017
  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.


Condition Intervention Phase
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) Biological: NKR-2 cells Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Celyad (formerly named Cardio3 BioSciences):

Primary Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NKR-2 infusion [ Time Frame: 24 months ]
    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:
  • Clinical activity of the treatment in each tumor type [ Time Frame: 24 months ]
    Clinical activity of the treatment in each tumor type


Estimated Enrollment: 24
Study Start Date: December 2016
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hematological tumors
The dose escalation arm for hematological tumors will use a 3 +3 design to determine the maximum tolerated dose.
Biological: NKR-2 cells
The intervention will consist of an infusion of NKR-2 cells administered every 2 weeks (14 days) for a total of 3 infusions within 4 weeks (28 days).
Other Name: NKG2D CAR-T cells
Experimental: Solid Tumors
The dose escalation arm for solid tumors will use a 3 +3 design to determine the maximum tolerated dose.
Biological: NKR-2 cells
The intervention will consist of an infusion of NKR-2 cells administered every 2 weeks (14 days) for a total of 3 infusions within 4 weeks (28 days).
Other Name: NKG2D CAR-T cells

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03018405

Contacts
Contact: Rachel Allen, RN MPH 857-990-6900 Think_info@celyad.com

Locations
United States, Florida
H Lee Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Amy Whitworth    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Kunle Odunsi, MD PhD         
United States, Pennsylvania
University of Pittsburgh Cancer Institute Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Kim Auth       phase1@upmc.edu   
Principal Investigator: James Lee, MD PhD         
Belgium
Cliniques Universitaires St-Luc, Recruiting
Brussels, Belgium, 1200
Contact: Anne Moxhon    +32 2 764.42.17    anne.moxhon@uclouvain.be   
Principal Investigator: Jean-Pascal Machiels, MD         
Universite Libre de Bruxelles (ULB) (Institut Jules Bordet),Medical Oncology Clinic Rue Héger-Bordet,1 Brussels 1000 Belgium Recruiting
Brussels, Belgium
Contact: Michel Dubuisson    +32 (0) 2 541 31 79    michel.dubuisson@bordet.be   
Principal Investigator: Ahmad Awada, MD         
Ghent University Hospital Recruiting
Ghent, Belgium
Contact: Jonas Segaert    32 (0)9 332 4912    jonas.segaert@uzgent.be   
Principal Investigator: Tesse Kerre, MD         
Sponsors and Collaborators
Celyad (formerly named Cardio3 BioSciences)
Investigators
Principal Investigator: Frédéric Lehmann, MD Celyad (formerly named Cardio3 BioSciences)
  More Information

Responsible Party: Celyad (formerly named Cardio3 BioSciences)
ClinicalTrials.gov Identifier: NCT03018405     History of Changes
Other Study ID Numbers: CYAD-N2T-002
Study First Received: January 10, 2017
Last Updated: May 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Colorectal Neoplasms
Multiple Myeloma
Pancreatic Neoplasms
Myelodysplastic Syndromes
Preleukemia
Carcinoma, Transitional Cell
Triple Negative Breast Neoplasms
Neoplasms, Plasma Cell
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on June 26, 2017