NK Cells Infusion for Advanced Malignancies

NCT03619954 | Unknown Phase 1

• 1 other identifier: AHP2018070101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

NK cell infusion

Outcome Measures

Primary Outcomes (2)

• Successful expansion of NK cells in patient's circulatory system

  CD56 positive cells ≥100 cells/μL in blood is considered as successful expansion of NK cells

  7 days after the last treatment

• Objective Response Rate

  The percentage of patients who reach complete response（CR）or partial response （PR）after all treatment finished. The response is evaluated according to irRECIST.

  4 weeks after all the treatment finished

Secondary Outcomes (3)

• Overall survival

  1 and 2 years after treatment

• Disease progression free survival

  1 and 2 years after treatment

• Dynamic changes of NK cells number in blood

  Day 1,3,5,7,10,14,21,28 and 2, 3, 6 months after NK cells infusion finished

Study Arms (1)

NK cells infusion

EXPERIMENTAL

Biological: NK cells infusion

Interventions

NK cells infusion 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

NK cells infusion

Eligibility Criteria

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

You may qualify if:

• 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;
• Age 18-75 years old (≥18, ≤75);
• ECOG: 0-1;
• Expected survival period ≥ 3 months;
• Hematology tests also meet the following requirements:
• \) 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

You may not qualify if:

• 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);
• Patients with brain metastases (unless the investigator believes that brain metastasis is currently stable, it is generally not recommended for enrollment);
• Transplant recipients;
• T-cell lymphoma patients;
• Allergies to biologics used in this treatment;
• Patients with HIV and syphilis;
• HBV carriers;
• Patients who are undergoing radiation therapy or immunotherapy within 4 weeks;
• Patients who have undergone high-dose radiation therapy on the lung and liver within 4 months;
• Patients with pulmonary inflammation determined by chest radiography;
• Oxygen saturation ≤ 90% on room air;
• Patients with cachexia caused by advanced tumors;
• Long-term use of immunosuppressive drugs or patients who are using immunosuppressive drugs;
• Those with serious autoimmune diseases;
• 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);

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provincial cancer center

Hefei, Anhui, 230001, China

RECRUITING

Study Officials

• Yueyin Pan, PhD

  Anhui Province Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueyin Pan, PhD

CONTACT

86-551-62283411; yueyinpan1965@163.com

Wei Wang, MD

CONTACT

86-551-62283411; whouwei@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Medical Oncology

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 8, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

CN (1)