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Trial record 4 of 33 for:    nkg2d

Pilot Study of NKG2D-Ligand Targeted CAR-NK Cells in Patients With Metastatic Solid Tumours

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03415100
Recruitment Status : Unknown
Verified July 2018 by The Third Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : January 30, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
The Third Affiliated Hospital of Guangzhou Medical University

Brief Summary:
This is a single-centre, single arm, open-label pilot study to evaluate the safety and feasibility of CAR-NK cell treatment in subjects with metastatic solid tumours. Autologous or allogeneic NK cells are transfected by mRNA electroporation to prepare investigational CAR-NK cells with transiently enhanced specificity and activity against NKG2D-ligand expressing cancer cells.

Condition or disease Intervention/treatment Phase
Solid Tumours Biological: CAR-NK cells targeting NKG2D ligands Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of NKG2D-Ligand Targeted CAR-NK Cells in Patients With Metastatic Solid Tumours
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: CAR-NK cells targeting NKG2D ligands Biological: CAR-NK cells targeting NKG2D ligands
The infusion of CAR-NK cells will be performed in the Third Affiliated Hospital of Guangzhou Medical University. Following infusion of CAR-NK cells, interleukin-2 (IL-2) will be injected subcutaneously into some patients to support the in vivo survival of CAR-NK cells. The subject will be observed for any side effects during this time and all the adverse events will be recorded.




Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: from day 0 - month 4 ]

Secondary Outcome Measures :
  1. Anti-tumour response due to CAR-NK cell infusions [ Time Frame: 100 days after CAR-NK cell infusion ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent form must be obtained prior to any research procedure.
  2. Histologically or cytologically confirmed diagnosis of metastatic solid tumours
  3. ECOG performance status of 0-3;
  4. Adequate organ function defined as: ANC≥1.0×10^9/L, PLT≥75×10^9/L, ALB≥25g/L, TBIL≤1.5×ULN, AST≤2.5×ULN, ALT≤2.5×ULN, ALP≤2.5×ULN, Cr≤1.5×ULN;
  5. The patient's own PBMCs or PBMCs from a biological parent or child who is willing to donate blood will be used to prepare CAR-NK cells. The parent or child should be ≥18 and ≤60 years old, and he or she is able to sign the informed consent for blood donation by himself/herself;
  6. Patients who won't benefit from surgery, or refuse surgical treatment; patients who won't benefit from chemotherapy, can't tolerate chemotherapy or refuse chemotherapy.
  7. Patients volunteer to participate in this study and sign the informed consent form for subjects;
  8. Blood donors sign the informed consent form for blood donors.
  9. Blood donors have negative test results for HIV, HBV and HCV;
  10. If a subject or blood donor is a female of childbearing potential, she must have a negative urine pregnancy test result.

Exclusion Criteria:

  1. Patients who are suffering from uncontrollable or active infectious diseases of the hematological system, cardiovascular system, respiratory system, digestive system, urinary system, or the endocrine system;
  2. Patients with immunologic deficiency or autoimmune diseases;
  3. Patients with severe hypersensitivity reactions;
  4. Patients received other forms of cellular therapies within the last 3 months;
  5. Patients received systemic steroids within the last 3 months;
  6. Patients who are breastfeeding or pregnant;
  7. Patients with brain metastases;
  8. Patients who have received an organ transplant.

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): NCT03415100


Contacts
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Contact: Xuehu Xu, MD +86 20-81292822 maxtiger@126.com
Contact: Lin Xiao, PhD +86 15871810198 linxiao120825@gmail.com

Locations
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China, Guangdong
Third Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510150
Contact: Lin Xiao, PhD    +86 15871810198    linxiao120825@gmail.com   
Sponsors and Collaborators
The Third Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: Xuehu Xu, MD The Third Affiliated Hospital of Guangzhou Medical University
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Responsible Party: The Third Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03415100    
Other Study ID Numbers: NRC-NK-01
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms