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
Qualifiers
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
Treatments tested in this trial
- Armored Dendritic Cell Injection
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov