Treatment of Malignant Tumors With Antigen Peptide-specific DC-CTL Cells and Decitabine

Tumor-specific antigens can be induced by demethylation drugs. Antigen-targeting DC-CTL cells supposed to eliminate cancer cells efficiently and specifically. In this study investigators co-culture DCs cells with peptides derived from tumor specific antigen to generate antigen-specific DC-CTLs (Ag-CTL). Following treatment with demethylation drugs, Ag-CTL will be used to eliminate tumor cells. This study aims to evaluate the effectiveness and safety of Ag-CTL combined with demethylation drugs.

Study Overview

• Status: Recruiting
• Conditions: Malignant Tumor
• Intervention / Treatment: Biological: DC-CTL

Detailed Description

A large number of studies have confirmed that demethylated drug decitabine can effectively induce tumor-specific antigen expression. Tumor-specific antigens have strong specificity and are ideal therapeutic targets. In this study, tumor-specific antigens were used as therapeutic targets. The researchers screened the tumor-specific epitope peptides through bioinformatics database combined with in vitro experiments. The peptide-loaded DCs are co-cultured with T lymphocytes to induce the proliferation of CTLs, which are then refusion to tumor patients to treating diseases.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shujiao He, Dr; Phone Number: 0755-21838178; Email: he_shujiao@126.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • Shenzhen University General Hospital
      • Contact: Shujiao He, Dr; Phone Number: 0755-21838178; Email: he_shujiao@126.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 (including 18 and 70 years old);
2. Diagnosed as malignant tumor by pathological and histological examination;
3. Patients with ECOG score <2 and estimated survival time>3 months;
4. Patients need to receive systemic combined chemotherapy according to their condition; other treatments such as surgery, radiotherapy, and targeted therapy are excluded;
5. The previous treatment-related toxicity of the patient 2 weeks before the enrollment had returned to <1 grade at the time of enrollment (except for low-grade toxicity such as alopecia and peripheral neuritis);
6. The patient's intravenous access is unobstructed, which can meet the needs of intravenous drip;
7. The patient voluntarily participates and signs the informed consent form, and follows the research treatment plan and visit plan;

Exclusion Criteria:

• Any one of the exclusion criteria shall not be included in the group:

  1. Patients used high-dose hormones within 1 week before enrollment (except for patients using inhaled hormones)
  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. The patient had uncontrollable infections within 4 weeks before enrollment;
  5. Active HBV DNA>1000copy/mL/C hepatitis (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive;
  6. The patient participated in other clinical studies within 6 weeks before enrollment;
  7. Patients suffering from mental illness;
  8. 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;
  9. The patient has alcohol dependence;
  10. 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;
  11. According to the judgment of the investigator, the patient has other unsuitable conditions for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; DAC combined with Ag-CTL	Biological: DC-CTL; DAC combined with Ag-CTL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression free survival time	From date of initial treatment until the date of first documented progression, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	over all survival time	From date of diagnosis until the end of the follow-up, assessed up to 36 months.

Collaborators and Investigators

• Sponsor: Shenzhen University General Hospital
• Investigators: Principal Investigator: Li Yu, Professor, Shenzhen University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Anticipated): July 28, 2023
• Study Completion (Anticipated): July 28, 2023

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ONCO-DCCTL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No