NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors

NCT ID: NCT05528341

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2026-04-30

Brief 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.

Conditions

Relapsed/Refractory Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NKG2D-CAR-NK92 cells immunotherapy

Preparation of NKG2D-CAR-NK92 cells suspended in saline solution.

Group Type: EXPERIMENTAL

NKG2D-CAR-NK92 cells

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinxiang medical university

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wuling Zhu

Role: CONTACT

wulingzhu@xxmu.edu.cn

008603733029089

Facility Contacts

Professor Lu

Role: primary

13598722864

Other Identifiers

CNK-102

Identifier Type: -

Identifier Source: org_study_id