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

Sponsor
Shenzhen University General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04672473
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
32.9
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: DC-CTL
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Malignant Tumors With Antigen Peptide-specific DC-CTL Cells and Decitabine
Actual Study Start Date :
Oct 30, 2020
Anticipated Primary Completion Date :
Jul 28, 2023
Anticipated Study Completion Date :
Jul 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

DAC combined with Ag-CTL

Biological: DC-CTL
DAC combined with Ag-CTL

Outcome Measures

Primary Outcome Measures

  1. PFS [From date of initial treatment until the date of first documented progression, assessed up to 36 months.]

    progression free survival time

Secondary Outcome Measures

  1. OS [From date of diagnosis until the end of the follow-up, assessed up to 36 months.]

    over all survival time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shenzhen University General Hospital Shenzhen Guangdong China 518000

Sponsors and Collaborators

  • Shenzhen University General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
YuLi, Professor, Shenzhen University General Hospital
ClinicalTrials.gov Identifier:
NCT04672473
Other Study ID Numbers:
  • ONCO-DCCTL-001
First Posted:
Dec 17, 2020
Last Update Posted:
Dec 17, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Dec 17, 2020