Solid Tumours
Conditions
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.
Interventions
BIOLOGICALCAR-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.
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | from day 0 - month 4 |
Secondary
| Measure | Time frame |
|---|---|
| Anti-tumour response due to CAR-NK cell infusions | 100 days after CAR-NK cell infusion |
Countries
China
Contacts
Primary ContactXuehu Xu, MD
Backup ContactLin Xiao, PhD
Outcome results
None listed