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

The Third Affiliated Hospital of Guangzhou Medical University

Status and phase: Unknown; Phase 1

Conditions: Solid Tumours

Treatments: Biological: CAR-NK cells targeting NKG2D ligands

Study type: Interventional

Funder types: Other

Identifiers

NCT03415100

NRC-NK-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

CAR-NK cells targeting NKG2D ligands

Experimental group

Treatment:

Biological: CAR-NK cells targeting NKG2D ligands