Clinical Study of DC-CIK Cells as a Post-remission Treatment for Malignant Tumors

Clinical Study of Descitabine Enhanced Infusion of Autologous DC-CIK Cells as a Post-remission Treatment for Malignant Tumors

1. Screening stage
2. Evaluation of disease
3. Grouping of patients
4. Infusion of cells
5. Surveillance of adverse effect

Study Overview

• Status: Unknown
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Drug: Decitabine; Biological: DC-CIK

Detailed Description

1. Screening stage：All patients must be confirmed by pathology priorily and reachead remission after surgery or chemo- or radiotherapy. All criteria patients must sign informed consent in advance.
2. Evaluation of disease: Systematically assessment of tumor burdern and Physical fitness of all patients.
3. Cell preparation：At least one month after the end of the last chemotherapy, 100ml of peripheral blood was collected, and PBMCs were separated and extracted in the tens of thousands and local hundreds of clean laboratories and DC-CIK cells were prepared.
4. Baseline assessment: Systematically assess various biochemical indicators. Those who do not meet the infusion criteria will withdraw from the study after being confirmed by researchers.
5. Study group: All subjects were randomly divided into test group and control group. The test group was treated with decitabine. The course of treatment was a total of 5 times.
6. Infusion：During cell culture and before transfusion, cells should be subjected to strict quality control tests such as bacteria, fungi, mycoplasma, endotoxin, cell activity, DC and T cell identification, etc. The transfusion can be approved only after the quality control is qualified.
7. Adverse reaction monitoring: DC-CIK infusion was used to closely observe changes in subjects' blood pressure, body temperature, blood routine, blood biochemistry, electrolytes, coagulation, cytokines and organ functions.
8. After the trial is completed, the patient's survival information will be followed up every 3 months by telephone or by visiting the test center.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shenzhen, China, 518000
    • Recruiting
    • Shenzhen University General Hospital
    • Contact: LI Yu, Doctor; Phone Number: +8675521839215; Email: liyu301@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients aged 18-70 years (including 18 and 70 years);
2. Pathological and histological examination confirmed a malignant solid tumor;
3. Patients with ECOG score <2, estimated survival time> 3 months.
4. Patients with solid tumors have cleared their lesions after treatment, and are unsuitable or unwilling to receive other anti-tumor treatments such as chemotherapy and radiotherapy;
5. Patients did not receive any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within 2-4 weeks before enrollment, and their previous treatment-related toxicities have recovered to <1 (hair loss) , Except for low-level toxicity such as peripheral neuritis);
6. The patient's venous channel is unobstructed, which can meet the needs of intravenous drip;
7. Patients voluntarily participate and sign informed consent, and follow the research treatment plan and visit plan.

Exclusion Criteria:

• 1. Patients use large doses of hormones (except for patients using inhaled hormones) within 1 week before enrollment; 2. People with severe autoimmune diseases, immunodeficiency diseases or severe allergies; 3. Patients treated with other cellular immune products (DC, T, NK, and CAR-T, etc.); 4. Patients have uncontrollable infections within 4 weeks before enrollment; 5. Active HBV DNA> 1000copy / mL / Hepatitis C virus (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive; 6. Patients participated in other clinical studies within 6 weeks before enrollment; 7. Patients with mental illness; 8. Patients with a substance abuse / addiction and medical, psychological or social conditions that may interfere with the study or influence the evaluation of the study results; 9. Alcohol dependence in patients; 10. Women who are pregnant (positive urine / blood pregnancy study) or breastfeeding; men or women with a pregnancy plan in the past year; patients cannot guarantee effective contraception during the study period 11. At the discretion of the investigator, the patient has other unsuitable conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decitabine combined with DC-CIK; Test group: decitabine combined with autologous DC-CIK cells infusion: decitabine 10mg / d, intravenous administration of d-5 to d-1, autologous DC-CIK cells infusion: first course: d1-d3 The second course: d14-d16; the total number of cells is about 5-10 × 109; IL-2: 200,000 IU / d subcutaneous injection, the first course: d0-d4, the second course: d13-d17, every 2 weeks 1 course of treatment, 2 courses in total.	Drug: Decitabine; Decitabine 10mg / d, intravenous administration d-5 ～ d-1; Biological: DC-CIK; Autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109;
Active Comparator: DC-CIK; Control group: autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109; One course: d0-d4, the second course: d13-d17, 1 course every 2 weeks, a total of 2 courses.	Biological: DC-CIK; Autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival rate	up to 2 years
PFS	progression free survival	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
objective response rate	up to 2 years

Collaborators and Investigators

• Sponsor: Li Yu

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Anticipated): January 20, 2023
• Study Completion (Anticipated): January 20, 2023

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Decitabine; dendritic cell-cytokine induced killer
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• Other Study ID Numbers: ONCO-CIK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No