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

Solid Tumours Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03415100
• Other study ID #: NRC-NK-01
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Solid Tumours

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