An Antibody-armored Dendritic Cell in Patients With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Cell Therapy Group Co.,Ltd
About this trial
This study is a single-arm, open-label, single-administration dose-escalation study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 80 years, body weight ≥ 40 kg; male or female, no gender restriction;
ECOG performance status score of 0 to 1;
Histopathologically confirmed solid tumors including pancreatic cancer, colorectal cancer (CRC), gastric cancer and other such malignancies;
Having undergone R0 or R1 resection with completion of at least 4 cycles of standard postoperative adjuvant chemotherapy;
Disqualifiers
Women who are pregnant or breastfeeding;
Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody; positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (anti-HBc) or hepatitis B e antibody (anti-HBe) with hepatitis B virus (HBV) DNA copy number above the lower limit of detection (LLOD) or ≥ 1000 copies/mL; or hepatitis C virus (HCV) RNA copy number above the LLOD;
Prior treatment with any dendritic cell (DC) or other immune cell therapy;
History of hypersensitivity to immunotherapy and related drugs, or history of severe allergic reactions;
Trial design
Design model
Single group
Treatments tested in this trial
Armored Dendritic Cell Injection
Biological/VaccineArmored dendritic cells are administered via multiple subcutaneous injections.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Armored Dendritic Cell InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose
Time frame
Day 0-Month 52
Evaluate the incidence and severity of adverse events
Adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities (including their types, frequencies and severity) will be collected. This includes the types, incidence and severity of adverse events, as well as clinically significant abnormal laboratory test results and abnormal physical examination findings that emerge after treatment. Clinical and laboratory adverse events will be primarily graded using Version 6.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). The causal relationship between adverse events and the dendritic cell (DC) product will be assessed by investigators in accordance with the causality evaluation criteria specified in the study protocol.
Time frame
Day 0-Month 24Secondary outcomes
1
Cmax
Time frame
day 0-day282
antigen-specific T-cell responses
Time frame
day 0-Month 53
RFS
1- and 2-year recurrence-free survival rates (RFS)
Time frame
day 0-Month 244
Tmax
Time frame
day 0- day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov