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

Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672473
• Other study ID #: ONCO-DCCTL-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 30, 2020
• Est. completion date: July 28, 2023

Study information

• Verified date: December 2020
• Source: Shenzhen University General Hospital
• Contact: Shujiao He, Dr
• Phone: 0755-21838178
• Email: he_shujiao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Biological:
• DC-CTL
DAC combined with Ag-CTL

Locations

Country	Name	City	State
China	Shenzhen University General Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression free survival time	From date of initial treatment until the date of first documented progression, assessed up to 36 months.
Secondary	OS	over all survival time	From date of diagnosis until the end of the follow-up, assessed up to 36 months.