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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.
Verified August 2017 by Celyad (formerly named Cardio3 BioSciences)
Sponsor:
ClinicalTrials.gov Identifier:
NCT03018405
First Posted: January 12, 2017
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Celyad (formerly named Cardio3 BioSciences)
  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: None (Open Label)
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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018405


Contacts
Contact: Jim Kostka Think_info@celyad.com
Contact: Bikash Verma bverma@celyad.com

Locations
United States, Florida
Recruiting
Tampa, Florida, United States, 33612
Contact: Jeff Edelman    813-745-1040    Jeffrey.Edelman@moffitt.org   
United States, New York
Recruiting
Buffalo, New York, United States, 14263
Contact: Amy Whitworth    877-275-7724    ASKRPCI@roswellpark.org   
United States, Pennsylvania
Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Kim Auth       phase1@upmc.edu   
Belgium
Recruiting
Brussels, Belgium, 1200
Contact: Anne Moxhon    +32 2 764.42.17    anne.moxhon@uclouvain.be   
Recruiting
Brussels, Belgium
Contact: Michel Dubuisson    +32 (0) 2 541 31 79    michel.dubuisson@bordet.be   
Recruiting
Ghent, Belgium
Contact: Jonas Segaert    32 (0)9 332 4912    jonas.segaert@uzgent.be   
Contact: Liesbeth Delanghe       Liesbeth.delanghe@uzgent.be   
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
First Submitted: January 10, 2017
First Posted: January 12, 2017
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Colorectal Neoplasms
Multiple Myeloma
Pancreatic Neoplasms
Myelodysplastic Syndromes
Preleukemia
Triple Negative Breast Neoplasms
Carcinoma, Transitional Cell
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