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

NCT ID: NCT04672473

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2023-07-28

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.

Conditions

Malignant Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

DAC combined with Ag-CTL

Group Type: EXPERIMENTAL

DC-CTL

Intervention Type: BIOLOGICAL

DAC combined with Ag-CTL

Interventions

DC-CTL

DAC combined with Ag-CTL

Intervention Type: BIOLOGICAL

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

YuLi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Yu, Professor

Role: PRINCIPAL_INVESTIGATOR

Shenzhen University General Hospital

Locations

Shenzhen University General Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shujiao He, Dr

Role: CONTACT

Phone: 0755-21838178

Email: he_shujiao@126.com

Facility Contacts

Shujiao He, Dr

Role: primary

Other Identifiers

ONCO-DCCTL-001

Identifier Type: -

Identifier Source: org_study_id