Status:
UNKNOWN
Pilot Study of NKG2D-Ligand Targeted CAR-NK Cells in Patients With Metastatic Solid Tumours
Lead Sponsor:
The Third Affiliated Hospital of Guangzhou Medical University
Conditions:
Solid Tumours
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Signed informed consent form must be obtained prior to any research procedure.
- Histologically or cytologically confirmed diagnosis of metastatic solid tumours
- ECOG performance status of 0-3;
- 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;
- 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;
- 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.
- Patients volunteer to participate in this study and sign the informed consent form for subjects;
- Blood donors sign the informed consent form for blood donors.
- Blood donors have negative test results for HIV, HBV and HCV;
- If a subject or blood donor is a female of childbearing potential, she must have a negative urine pregnancy test result.
Exclusion
- 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;
- Patients with immunologic deficiency or autoimmune diseases;
- Patients with severe hypersensitivity reactions;
- Patients received other forms of cellular therapies within the last 3 months;
- Patients received systemic steroids within the last 3 months;
- Patients who are breastfeeding or pregnant;
- Patients with brain metastases;
- Patients who have received an organ transplant.
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03415100
Start Date
January 2 2018
End Date
December 1 2019
Last Update
August 1 2018
Active Locations (1)
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1
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150