Clinical trial · Interventional
Pilot Study of NKG2D-Ligand Targeted CAR-NK Cells in Patients With Metastatic Solid Tumours
NCT03415100CI-TRIAL-00034091unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-NK cells targeting NKG2D ligands | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-NK cells targeting NKG2D ligands
- interventionNames
- Biological: CAR-NK cells targeting NKG2D ligands
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- from day 0 - month 4
Secondary outcomes (1)
- measure
- Anti-tumour response due to CAR-NK cell infusions
- timeFrame
- 100 days after CAR-NK cell infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDNg YY, Du Z, Zhang X, Chng WJ, Wang S. CXCR4 and anti-BCMA CAR co-modified natural killer cells suppress multiple myeloma progression in a xenograft mouse model. Cancer Gene Ther. 2022 May;29(5):475-483. doi: 10.1038/s41417-021-00365-x. Epub 2021 Sep 1. PMID 34471234