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

NCT04672473 | Unknown Phase 1

• 1 other identifier: ONCO-DCCTL-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival time

  From date of initial treatment until the date of first documented progression, assessed up to 36 months.

Secondary Outcomes (1)

• OS

  From date of diagnosis until the end of the follow-up, assessed up to 36 months.

Study Arms (1)

Treatment

EXPERIMENTAL

DAC combined with Ag-CTL

Biological: DC-CTL

Interventions

DC-CTL BIOLOGICAL

DAC combined with Ag-CTL

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18-70 (including 18 and 70 years old);
• Diagnosed as malignant tumor by pathological and histological examination;
• Patients with ECOG score \<2 and estimated survival time\>3 months;
• Patients need to receive systemic combined chemotherapy according to their condition; other treatments such as surgery, radiotherapy, and targeted therapy are excluded;
• 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);
• The patient's intravenous access is unobstructed, which can meet the needs of intravenous drip;
• The patient voluntarily participates and signs the informed consent form, and follows the research treatment plan and visit plan;

You may not qualify if:

• Patients used high-dose hormones within 1 week before enrollment (except for patients using inhaled hormones)
• People with severe autoimmune diseases, immunodeficiency diseases or severe allergies;
• Patients treated with other cellular immune products (DC, T, NK, and CAR-T, etc.);
• The patient had uncontrollable infections within 4 weeks before enrollment;
• Active HBV DNA\>1000copy/mL/C hepatitis (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive;
• The patient participated in other clinical studies within 6 weeks before enrollment;
• Patients suffering from mental illness;
• 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;
• The patient has alcohol dependence;
• 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;
• According to the judgment of the investigator, the patient has other unsuitable conditions for enrollment.

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Li Yu, Professor

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shujiao He, Dr

CONTACT

0755-21838178; he_shujiao@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: October 30, 2020
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)