NK Cells Infusion for Advanced Malignancies

NCT ID: NCT03619954

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-07-01

Brief Summary

This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients

Conditions

Immunotherapy

Study Design

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

Study Groups

NK cells infusion

Group Type: EXPERIMENTAL

NK cells infusion

Intervention Type: BIOLOGICAL

Pretreatment：patients enrolled in this study will receive 20 mg/kg of cyclophosphamide for solid tumor or 20-60 mg/kg of cyclophosphamide for hematological tumor once daily for 3 times. NK cells infusion is allowed within 2-14 days after treatment.

NK cells infusion：30-60 minutes before infusion，ant-allergic agents are applied (promethazine 25mg,i.m. ; Cimetidine 0.4g i.v. ; diphenhydramine 50mg po.). NK cells are intravenously infused into patients with 15-30 minutes every other day for one to three times. The number of every infused NK cells is 1-3×10^7/kg, counted as the number of CD56+ cells. Patients with severe pleural or ascites can also receive pleural or abdominal cavity perfusion simultaneously. The total number of infused NK cells is no more than 5×10^9 cells. 4 hours after NK cells infusion，IL-2 is applied every other day for six times

Interventions

NK cells infusion

Pretreatment：patients enrolled in this study will receive 20 mg/kg of cyclophosphamide for solid tumor or 20-60 mg/kg of cyclophosphamide for hematological tumor once daily for 3 times. NK cells infusion is allowed within 2-14 days after treatment.

NK cells infusion：30-60 minutes before infusion，ant-allergic agents are applied (promethazine 25mg,i.m. ; Cimetidine 0.4g i.v. ; diphenhydramine 50mg po.). NK cells are intravenously infused into patients with 15-30 minutes every other day for one to three times. The number of every infused NK cells is 1-3×10^7/kg, counted as the number of CD56+ cells. Patients with severe pleural or ascites can also receive pleural or abdominal cavity perfusion simultaneously. The total number of infused NK cells is no more than 5×10^9 cells. 4 hours after NK cells infusion，IL-2 is applied every other day for six times

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patients with advanced malignant tumors diagnosed by pathological histology and/or cytology who have failed multi-line therapy and have no standard treatment method are unable to undergo surgery, radiation therapy, or chemotherapy;

2. Age 18-75 years old (≥18, ≤75);

3. ECOG: 0-1;

4. Priority should be given to the inclusion of ovarian cancer, malignant leukemia, lymphoma, etc. that have been shown to respond well to NK cell therapy;

5. Expected survival period ≥ 3 months;

6. Hematology tests also meet the following requirements:

1) WBC≥3×109/L, ANC≥1.5×109/L, Hb≥90g/L, PLT≥100×109/L; 2) TBIL ≤ 1.5 × ULN (normal upper limit), ALT and AST ≤ 2 × ULN (if there is liver metastasis, then ≤ 5 × ULN); 3) Endogenous creatinine clearance ≥ 60 ml/min (calculated based on Cockcroft-Gault formula); (7) Length of solid tumors do not exceed 6 cm; (8) Signing of informed consent from each patient

Exclusion Criteria

1. History of other malignancies with a disease-free period <5 years (except for cured basal cell carcinoma of the skin, cured carcinoma of the cervix in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection);

2. Patients with brain metastases (unless the investigator believes that brain metastasis is currently stable, it is generally not recommended for enrollment);

3. Transplant recipients;

4. T-cell lymphoma patients;

5. Allergies to biologics used in this treatment;

6. Patients with HIV and syphilis;

7. HBV carriers;

8. Patients who are undergoing radiation therapy or immunotherapy within 4 weeks;

9. Patients who have undergone high-dose radiation therapy on the lung and liver within 4 months;

10. Patients with pulmonary inflammation determined by chest radiography;

11. Oxygen saturation ≤ 90% on room air;

12. Patients with cachexia caused by advanced tumors;

13. Long-term use of immunosuppressive drugs or patients who are using immunosuppressive drugs;

14. Those with serious autoimmune diseases;

15. Patients with organ failure (grade 4 of heart function; liver function with Child class C or above; brain metastasis with disturbance of consciousness; severe respiratory failure symptoms);

16. Active infections (including intra-abdominal infections).

17. Researchers consider it inappropriate to participate in the trial

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

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yue-Yin Pan

Professor of Department of Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yueyin Pan, PhD

Role: PRINCIPAL_INVESTIGATOR

Anhui Province Cancer Center

Locations

Anhui Provincial cancer center

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yueyin Pan, PhD

Role: CONTACT

yueyinpan1965@163.com

86-551-62283411

Wei Wang, MD

Role: CONTACT

whouwei@gmail.com

86-551-62283411

Facility Contacts

Yue-Yin Pan, PhD

Role: primary

yueyinpan1965@163.com

0086-551-62283411

Wei Wang, MD

Role: backup

whouwei@gmail.com

0086-551-62283411

Other Identifiers

AHP2018070101

Identifier Type: -

Identifier Source: org_study_id