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

Last updated: July 31, 2018
Sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Overall Status: Active - Recruiting

Phase

1

Condition

All Solid Tumors

Treatment

N/A

Clinical Study ID

NCT03415100
NRC-NK-01
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 todonate blood will be used to prepare CAR-NK cells. The parent or child should be ≥18and ≤60 years old, and he or she is able to sign the informed consent for blooddonation by himself/herself;

  6. Patients who won't benefit from surgery, or refuse surgical treatment; patients whowon'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 forsubjects;

  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 anegative urine pregnancy test result.

Exclusion

Exclusion Criteria:

  1. Patients who are suffering from uncontrollable or active infectious diseases of thehematological 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.

Study Design

Total Participants: 30
Study Start date:
January 02, 2018
Estimated Completion Date:
December 31, 2019

Connect with a study center

  • Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510150
    China

    Active - Recruiting

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