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

Shenzhen University General Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Malignant Tumor

Treatments: Biological: DC-CTL

Study type: Interventional

Funder types: Other

Identifiers

NCT04672473

ONCO-DCCTL-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Treatment

Experimental group

Description:

DAC combined with Ag-CTL

Treatment:

Biological: DC-CTL