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NCT Number: NCT05528341

NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors

The purpose of this clinical investigation is to evaluate the safety and effects of NKG2D-CAR-NK92 infusions in the treatment of relapsed/refractory solid tumors.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The first Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453000, China

Location status: Recruiting

Location contact

Professor Lu

CONTACT

13598722864

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥ 18 years old and ≤ 75 years old, male or female.
  • Histopathology confirmed the diagnosis of malignant tumors (including breast cancer, lung cancer, gastric cancer, ovarian cancer, cervical cancer, renal carcinoma, malignant melanoma, osteosarcoma and lymphoma).
  • Expected survival time ≥3 months.
  • Disease must be measurable according to the corresponding guidelines.
  • Fail or unwilling to receive third-line treatment.
  • ECOG: 0-2.
  • The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
  • HB≧90g/L, ANC≧1.5×10^9/L, PLT≧80×10^9/L, TBIL≦1.5×upper limit of normal, ALT/AST≦2.5×upper limit of normal, ALT/AST≦5×upper limit of normal if have liver metastasis, Cr≦1.5×upper limit of normal or CCr≧60ml/min.
  • Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;
  • Written informed consent form must be signed before enrollment.
  • Patient with MICA/B+ cell tumors confirmed by pathology and histology.

Exclusion criteria

  • The patient has other malignancies or has been diagnosed with other malignancies within the last 5 years (except clinically cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, and thyroid papillary carcinoma).
  • Patients with brain metastases with symptoms or with symptom control for less than 3 months.
  • Active autoimmune disease.
  • Severe autoimmune diseases or congenital immunodeficiency.
  • Concomitant serious infection or other serious underlying medical condition.
  • Active hepatitis patients (including hepatitis B and C).
  • History of severe immediate hypersensitivity to any of the biological products including penicillin.
  • Drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study.
  • Simultaneous participation in another clinical trial within 4 weeks.
  • Cell therapy or gene therapy in the previous 1 month.
  • A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation.
  • Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.

Treatment and study plan

NKG2D-CAR-NK92 cells

Biological

NKG2D-CAR-NK92 cells will be administered intravenously over 1h. The starting dose of NKG2D-CAR-NK92 cells will be 0.5×10^6-2×10^6/kg, twice a week. The first evaluation of the efficacy after 3 weeks of treatment.

Primary outcomes

  1. Number of participants with adverse events evaluated with CTCAE, version 4.0

    Time frame: 3 months

    Safety evaluation

  2. Objective Response Rate

    Time frame: up to one year

    Solid tumors to NKG2D-CAR-NK92 cells infusions

Secondary outcomes

  1. Disease Control Rate

    Time frame: up to one year

  2. Progression-free Survival

    Time frame: up to one year

  3. Overall Survival

    Time frame: up to one year

  4. Quality of Life Score

    Time frame: up to one year

    We use the 26 items self-rating questionnaire WHOQOL-BREF to assess the Quality of Life Score, which measures physical health, psychological health, social relationships, and environment during the last two weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Wuling Zhu

CONTACT

[email protected]

008603733029089

Sponsors and collaborators

Lead sponsor

Henan Medical University

Other

Registry information

Official study title

Clinical Investigation of NKG2D-CAR-NK92 Chimeric Antigen Receptor Modified NK92 Cells in the Treatment of Relapsed/Refractory Solid Tumors

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 6, 2022
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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