NKG2D-CAR-NK92 cell therapy for solid tumors

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

This study is testing a new type of immune cell therapy to see if it can help adults with solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Henan Medical University (Academic / other)
• Locations: 1 site (Xinxiang, Henan)
• Trial ID: NCT05528341 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with confirmed malignant tumors who have failed or are unwilling to undergo third-line treatment.

Not a fit: Patients with solid tumors that are not measurable or those who have not met the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat solid tumors.

How similar studies have performed: While the use of CAR-NK cells is a novel approach, similar studies involving CAR-T cell therapies have shown promising results in treating various cancers.

Eligibility criteria

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 this trial is running

Xinxiang, Henan

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

Study contacts

• Study coordinator: Wuling Zhu

Conditions Relapsed/Refractory Solid Tumors