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

Phase 1

• Conditions: Solid Tumours
• Interventions: Biological: CAR-NK cells targeting NKG2D ligands

• Registration Number: NCT03415100
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-NK cells targeting NKG2D ligands	CAR-NK cells targeting NKG2D ligands	-

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	from day 0 - month 4

Secondary Outcome Measures

Name	Time	Method
Anti-tumour response due to CAR-NK cell infusions	100 days after CAR-NK cell infusion

Trial Locations

Locations (1)

Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China