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Trial Title:
NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors
NCT ID:
NCT05528341
Condition:
Relapsed/Refractory Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
NKG2D-CAR-NK92 cells
Description:
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.
Arm group label:
NKG2D-CAR-NK92 cells immunotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The first Affiliated Hospital of Xinxiang Medical University
Address:
City:
Xinxiang
Zip:
453000
Country:
China
Status:
Recruiting
Contact:
Last name:
Professor Lu
Phone:
13598722864
Start date:
January 26, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
Xinxiang medical university
Agency class:
Other
Source:
Xinxiang medical university
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05528341
