Clinical Study on Anti-tumor Effect Induced by Activated Primary Natural Killer（NK）Cells

NCT03634501 | Unknown Phase 1 DMC

• 1 other identifier: XuanWuH-NK
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will analyze and evaluate the following items:

1. 1.The safety of natural killer（NK） cells for treatment of subjects with solid tumors. Forty patients will be enrolled for each of the five cancers (in total 200 patients will be enrolled).
2. 2.The effectiveness of natural killer（NK）cell therapy alone or with chemotherapy or targeted drugs.
3. 3.Clinical assessment, and history of medications;
4. 4.Blood draws for routine and research tests, including but not limited to: lymphocyte population and circulating tumor cell analysis in peripheral blood;
5. 5.CT scan, bone scan and positron emission tomography（PET ）scan, if indicated, for disease evaluation;
6. 6.Pharmacokinetics study after NK infusion. For this test, the number of NK cells in the blood is measured over time at indicated time-points.

Conditions

Lung Cancer; Breast Cancer; Colon Cancer; Pancreatic Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of toxicity induced by NK infusion

  The incidence of toxicity within each infusion within 6 months after NK administration

  6 months

Secondary Outcomes (2)

• Objective-response rate (ORR)

  6 months after 6 infusions of NK administration

• Persistence of NK

  Day 0, Day 7, Day30, Day 60, Day 90, Day 180

Study Arms (1)

NK cells

EXPERIMENTAL

Activated NK from peripheral blood and/or umbilical cord blood（UCB）

Biological: Activated NK

Interventions

Activated NK BIOLOGICAL

Cell suspension

NK cells

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 from 18 to 75 years (including boundary values);
• Diagnosed with histologically and cellularly confirmed cancer of lung, breast, pancreas, ovary, or colon;
• At least 8 weeks since any prior systemic therapy to treat the underlying malignancy (standard or investigational);
• Life expectancy \> 6 months, and performance status（KPS）\> 60 points;
• Organ functions meet the following criteria:
• Blood bilirubin \< 2mg/dL,
• Aspartate transaminase（AST）\<100 IU/L,
• Alanine transaminase（ALT） \<100 IU/L,
• Creatinine \<1.5 mg/dL,
• Urea nitrogen ≤ 25 mg/dL,
• Hemoglobin ≥ 9.0 g/dL,
• White blood cell count\>3.5×109/L,
• Neutrophil count \>1.5x109/L,
• Platelet count \> 80 × 109 /L,
• Hematocrit \>0.20,

You may not qualify if:

• Subjects who take combined systemic steroids within 2 weeks prior to treatment (except inhaled steroids);
• Patients who take chemotherapy within 1 month prior to treatment;
• Subjects receiving drugs that stimulate the production of bone marrow hematopoietic cells within two weeks prior to treatment;
• Patients with T lymphoma and NK cell lymphoma;
• Patients with autoimmune diseases, including but not limited to lupus erythematosus, rheumatoid arthritis, etc.;
• Seriously uncontrollable infected patients;
• Patients who are allergic to the biological agents in this treatment;
• Patients with organ transplantation or organ failure;
• Subjects with severe cardiovascular disease and severe renal failure;
• Patients who are undergoing treatment of immunosuppressive drugs or long-term administration of immunosuppressive drugs after organ transplantation;
• Patients with active infection or fever;
• Subjects with severe cardiovascular and cerebrovascular diseases, diabetes and renal dysfunction;
• Subjects with pregnancy or during the lactating period.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Colonic Neoplasms; Pancreatic Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders

Study Officials

• Zhiguo Chen, PhD

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Zhiguo Chen, PhD

CONTACT

86-10-83198889; chenzhiguo@gmail.com

Yu Zhao, PhD

CONTACT

86-10-83198274

Study Design

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

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 16, 2018
• Study Start: October 26, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

CN (1)