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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03415100
Other study ID # NRC-NK-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 2, 2018
Est. completion date December 2019

Study information

Verified date July 2018
Source The Third Affiliated Hospital of Guangzhou Medical University
Contact Xuehu Xu, MD
Phone +86 20-81292822
Email maxtiger@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Third Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
The Third Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events from day 0 - month 4
Secondary Anti-tumour response due to CAR-NK cell infusions 100 days after CAR-NK cell infusion
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