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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04672473
Enrollment
60
Registered
2020-12-17
Start date
2020-10-30
Completion date
2023-07-28
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumor

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.

Interventions

BIOLOGICALDC-CTL

DAC combined with Ag-CTL

Sponsors

Shenzhen University General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PFSFrom date of initial treatment until the date of first documented progression, assessed up to 36 months.progression free survival time

Secondary

MeasureTime frameDescription
OSFrom date of diagnosis until the end of the follow-up, assessed up to 36 months.over all survival time

Countries

China

Contacts

Primary ContactShujiao He, Dr
he_shujiao@126.com0755-21838178

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026