Relapsed/Refractory Solid Tumors
Conditions
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.
Interventions
BIOLOGICALNKG2D-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.
Sponsors
Xinxiang medical university
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events evaluated with CTCAE, version 4.0 | 3 months | Safety evaluation |
| Objective Response Rate | up to one year | Solid tumors to NKG2D-CAR-NK92 cells infusions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | We use the 26 items self-rating questionnaire WHOQOL-BREF to assess the Quality of Life Score, which measures physical health, psychological health, social relationships, and environment during the last two weeks. |
Countries
China
Contacts
Primary ContactWuling Zhu
Outcome results
None listed