NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат NKG2D-CAR-NK92 cells
  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.

Первичные конечные точки

• Number of participants with adverse events evaluated with CTCAE, version 4.0 [Срок оценки: 3 months]
• Objective Response Rate [Срок оценки: up to one year]

Вторичные конечные точки (4)

• Disease Control Rate [Срок оценки: up to one year]
• Progression-free Survival [Срок оценки: up to one year]
• Overall Survival [Срок оценки: up to one year]
• Quality of Life Score [Срок оценки: up to one year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The first Affiliated Hospital of Xinxiang Medical University — Xinxiang

Идентификаторы

NCT: NCT05528341 · CNK-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗