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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malignant Tumor

Intervention / Treatment
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* Biological: DC-CTL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged 18-70 (including 18 and 70 years old); Diagnosed as malignant tumor by pathological and histological examination; Patients with ECOG score <2 and estimated survival time>3 months; Patients need to receive systemic combined chemotherapy according to their condition; other treatments such as surgery, radiotherapy, and targeted therapy are excluded; 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); The patient's intravenous access is unobstructed, which can meet the needs of intravenous drip; 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: 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 treated with other cellular immune products (DC, T, NK, and CAR-T, etc.); The patient had uncontrollable infections within 4 weeks before enrollment; Active HBV DNA>1000copy/mL/C hepatitis (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive; The patient 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 unsuitable conditions for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>DAC combined with Ag-CTL | Biological: DC-CTL<br>* DAC combined with Ag-CTL<br>|

What is the study measuring?
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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. |