Status:
UNKNOWN
Treatment of Malignant Tumors With Antigen Peptide-specific DC-CTL Cells and Decitabine
Lead Sponsor:
Shenzhen University General Hospital
Conditions:
Malignant Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 DC...
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 thera...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- Any one of the exclusion criteria shall not be included in the group:
- 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.
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 28 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04672473
Start Date
October 30 2020
End Date
July 28 2023
Last Update
December 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shenzhen University General Hospital
Shenzhen, Guangdong, China, 518000