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Status unknownNCT03415100Updated Aug 1, 2018

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

A Phase 1 interventional study of CAR-NK cells targeting NKG2D ligands in Solid Tumours, sponsored by The Third Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-01.

Sponsored by The Third Affiliated Hospital of Guangzhou Medical University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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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.

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Conditions studied

  • Solid Tumours

Browse trials for

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    CAR-NK cells targeting NKG2D ligands

    Biological: CAR-NK cells targeting NKG2D ligands

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.

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What researchers measure

Primary outcomes

  1. Number of Adverse Events

    Time frame: from day 0 - month 4

Secondary outcomes

  1. Anti-tumour response due to CAR-NK cell infusions

    Time frame: 100 days after CAR-NK cell infusion

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Study locations

1 of 1 sites recruiting
  • Third Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510150, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 34471234 ↗
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Registry details

Key details

Study ID
NCT03415100
Lead sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Responsible party
Sponsor
First posted
Jan 30, 2018
Start date
Jan 2, 2018
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 1, 2018

Study contacts

Xuehu Xu, MD
Contact
maxtiger@126.com
+86 20-81292822
Lin Xiao, PhD
Contact
linxiao120825@gmail.com
+86 15871810198
Xuehu Xu, MD
principal investigator · The Third Affiliated Hospital of Guangzhou Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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