NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors

NCT05528341 | Recruiting Phase 1

• 1 other identifier: CNK-102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events evaluated with CTCAE, version 4.0

  Safety evaluation

  3 months

• Objective Response Rate

  Solid tumors to NKG2D-CAR-NK92 cells infusions

  up to one year

Secondary Outcomes (4)

• Disease Control Rate

  up to one year

• Progression-free Survival

  up to one year

• Overall Survival

  up to one year

• Quality of Life Score

  up to one year

Study Arms (1)

NKG2D-CAR-NK92 cells immunotherapy

EXPERIMENTAL

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

Biological: NKG2D-CAR-NK92 cells

Interventions

NKG2D-CAR-NK92 cells 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.

NKG2D-CAR-NK92 cells immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinxiang medical university: lead

Study Sites (1)

The first Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453000, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wuling Zhu

CONTACT

008603733029089; wulingzhu@xxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 6, 2022
• Study Start: January 26, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)