Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Celconta Life Science Co., Ltd.
About this trial
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors
Eligibility criteria
Qualifiers
Age 18-75 (including the critical value), regardless of gender;
Patients with advanced solid tumors (including but not limited to gastric adenocarcinoma, esophagogastric junction adenocarcinoma, esophageal adenocarcinoma) with moderate to high expression of Claudin18.2 (expression intensity ≥ 2+ and tumor cell positive rate ≥ 50 %), and whose condition cannot be completely relieved or continues to progress after adequate treatment;
At least one measurable lesion according to RECIST 1.1 criteria (non-lymph node lesion with long diameter ≥10 mm, lymph node lesion with short diameter ≥15 mm);
Estimated life expectancy > 12 weeks;
Disqualifiers
Pregnant or breastfeeding women;
Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive, and HBV DNA copy number positive; Hepatitis C antibody (HCV-Ab) positive; Anti-Treponema pallidum antibody (TP-Ab) positive; Human immunodeficiency virus antibody (HIV-Ab) positive; Those who meet any of the following conditions;
Any active infection requiring antibiotic treatment;
Received any immune cell therapy within one year;
Trial design
Treatments tested in this trial
- XKDCT225
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov