NKG2D-CAR-NK92 cell therapy for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to evaluate the safety and efficacy of NKG2D-CAR-NK92 cell infusions in patients with relapsed or refractory solid tumors. The study will involve administering genetically modified natural killer (NK) cells that express the NKG2D receptor, which targets and destroys cancer cells. Participants will be monitored for treatment response and any adverse effects throughout the trial. The study is designed for adult patients who have not responded to standard treatments and have measurable disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: ≥ 18 years old and ≤ 75 years old, male or female.
2. 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).
3. Expected survival time ≥3 months.
4. Disease must be measurable according to the corresponding guidelines.
5. Fail or unwilling to receive third-line treatment.
6. ECOG: 0-2.
7. The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
8. 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.
9. 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;
10. Written informed consent form must be signed before enrollment.
11. Patient with MICA/B+ cell tumors confirmed by pathology and histology.

Exclusion Criteria:

1. 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).
2. Patients with brain metastases with symptoms or with symptom control for less than 3 months.
3. Active autoimmune disease.
4. Severe autoimmune diseases or congenital immunodeficiency.
5. Concomitant serious infection or other serious underlying medical condition.
6. Active hepatitis patients (including hepatitis B and C).
7. History of severe immediate hypersensitivity to any of the biological products including penicillin.
8. 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.
9. Simultaneous participation in another clinical trial within 4 weeks.
10. Cell therapy or gene therapy in the previous 1 month.
11. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation.
12. Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.

Where it's running

• The first Affiliated Hospital of Xinxiang Medical University
  Xinxiang, Henan, China Recruiting

Study contacts

• Study coordinator: Wuling Zhu
• Email: wulingzhu@xxmu.edu.cn
• Phone: 008603733029089

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.