Treatment of Malignant Tumors With NK Cell

NCT05143125 | Unknown Phase 1

• 1 other identifier: HEM-ONCO-009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Natural killer cells (NK cells) are derived from bone marrow lymphoid stem cells, which are a type of lymphocytes that can non-specifically kill tumor cells and virus-infected cells without pre-sensitization. NK cells can not only directly kill malignant diseased cells, but also participate in the regulation of immune cell response and play a role in a variety of tumor immunotherapy strategies. The 2-year survival rate of NK cells combined with stem cell therapy for patients with hematological malignancies reached 36%, which is significantly higher than the 2-year survival rate (about 15%) of stem cell therapy alone, which can extend the disease-free survival period of leukemia patients by an average of 1.5 years. Relapsed and refractory leukemia can achieve a complete remission rate of up to 40%.

Conditions

Malignancy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  DFS

  From date of initial treatment to the end of follow up, up to 2 years

Secondary Outcomes (1)

• Overall survival rate

  From admission to the end of follow up, up to 2 years.

Study Arms (1)

Treatment group

EXPERIMENTAL

Decitabine combined with NK cell infusion as post-remission therapy

Biological: Decitabine combined with NK cell infusion

Interventions

Decitabine combined with NK cell infusion BIOLOGICAL

Decitabine combined with NK cell infusion

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18-70 (including 18 and 70 years old);
• Those who have been diagnosed as malignant tumor by pathological and histological examination, have received anti-tumor treatment and are in remission;
• The ECOG score of the patient is less than 2 points;
• The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) and other anti-tumor treatments within 4 weeks before enrollment, and his previous treatment-related toxicity had returned to grade \<1 (hair loss, peripheral nerves) at the time of enrollment Except for low-level toxicity such as inflammation);
• The patient's intravenous access is unobstructed, which can meet the needs of intravenous drip;
• The patient voluntarily participates and signs an informed consent form, and follows the research treatment plan and visit plan.

You may not qualify if:

• The patients used high-dose hormones within 1 week before enrollment (except for patients using inhaled hormones);
• People with severe autoimmune diseases, immunodeficiency diseases or severe allergies;
• Patients who have been treated with other cellular immune products (DC, T, CTL, CAR-T, etc.);
• The patient had an uncontrollable infection within 4 weeks before enrollment;
• Active B HBV DNA\>1000copy/mL/C virus hepatitis (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive;
• The patient has participated in other clinical studies within 6 weeks before enrollment;
• Patients suffering from mental illness;
• The patient has drug abuse/addiction and medical, psychological or social conditions that may interfere with research or have an impact on the evaluation of research results;
• The patient has alcohol dependence;
• Women who are pregnant (positive urine/blood pregnancy studies) or breastfeeding; men or women who have a pregnancy plan within the past year; patients cannot be guaranteed to take effective contraceptive measures during the study period;
• According to the judgment of the investigator, the patient has other conditions that are not suitable for enrollment.

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General hospital

Shenzhen, Guangdong, 518055, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Li Yu, Dr

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yu, Dr

CONTACT

+8675521839178; liyu@vip.163.com

Study Design

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

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: February 5, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: December 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)