NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors

Official title

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

Overview

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.

Interventions

• Biological 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.

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The first Affiliated Hospital of Xinxiang Medical University — Xinxiang

Identifiers

NCT: NCT05528341 · CNK-102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗