NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors
Clinical Investigation of NKG2D-CAR-NK92 Chimeric Antigen Receptor Modified NK92 Cells in the Treatment of Relapsed/Refractory Solid Tumors
Henan Medical University
20 participants
Jan 26, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria12
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05528341