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

NCT03415100 | Unknown Phase 1

• 1 other identifier: NRC-NK-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumours

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  from day 0 - month 4

Secondary Outcomes (1)

• Anti-tumour response due to CAR-NK cell infusions

  100 days after CAR-NK cell infusion

Study Arms (1)

CAR-NK cells targeting NKG2D ligands

EXPERIMENTAL

Biological: CAR-NK cells targeting NKG2D ligands

Interventions

CAR-NK cells targeting NKG2D ligands BIOLOGICAL

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.

CAR-NK cells targeting NKG2D ligands

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

RECRUITING

Related Publications (1)

• Ng 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 DERIVED

Study Officials

• Xuehu Xu, MD

  The Third Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuehu Xu, MD

CONTACT

+86 20-81292822; maxtiger@126.com

Lin Xiao, PhD

CONTACT

+86 15871810198; linxiao120825@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: January 2, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

CN (1)