Clinical trial NCT04672473: Treatment of Malignant Tumors With Antigen Peptide-specific DC-CTL Cells and Decitabine
Official title: Treatment of Malignant Tumors With Antigen Peptide-specific DC-CTL Cells and Decitabine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Malignant Tumor
Lead sponsor: Shenzhen University General Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS
timeFrame: From date of initial treatment until the date of first documented progression, assessed up to 36 months.
Secondary outcomes:
measure: OS
timeFrame: From date of diagnosis until the end of the follow-up, assessed up to 36 months.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen University General Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen University General Hospital
name: Li Yu, Professor
role: PRINCIPAL_INVESTIGATOR
References: