Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)

NCT06782425 | Recruiting Phase 1

• 1 other identifier: 2023YP30H02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Claudin18.2 Positive Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  Dose limiting toxicity (DLT) in the dose escalation phase

  28 days of single infusion

• Maximum tolerated dose (MTD)

  Maximum tolerated dose (MTD) in the dose escalation phase

  28 days of single infusion

• The incidence and severity of adverse events (AEs) (%)

  The incidence and severity of AEs

  1 year

Secondary Outcomes (8)

• Pharmacokinetics (the number of CAR copies (copies/μg gDNA) in peripheral blood)

  1 year

• Peripheral blood cytokines

  1 year

• XKDCT293 immunogenicity assay

  1 year

• Objective response rate (ORR) (%)

  1 year

• Time to response (TTR) (month)

  1 year

Study Arms (1)

Autologous targeted claudin18.2 chimeric antigen receptor T cell injection

EXPERIMENTAL

Autologous targeted claudin18.2 chimeric antigen receptor T cell injection

Drug: XKDCT225

Interventions

XKDCT225 DRUG

Autologous targeted claudin18.2 chimeric antigen receptor T cell injection

Autologous targeted claudin18.2 chimeric antigen receptor T cell injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ECOG physical status score 0 \~ 1;
• Laboratory test values for screening must meet the following criteria:
• Routine blood test:
• WBC≥3.0×10\^9 /L
• ANC≥1.5×10\^9 /L
• LYMPH≥0.5×10\^9 /L
• HB≥90g/L
• PLT≥75×10\^9 /L
• Blood biochemistry examination:
• ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis is present)
• ALB≥30g/L

You may not qualify if:

• 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;
• Previously received Claudin18.2 targeted therapy ;
• Live vaccine or live attenuated vaccine received within 4 weeks before single collection;
• Surgery has been performed within 2 weeks before apheresis and the researchers believe that it may affect the patient's safety;
• Active coronary heart disease (including angina pectoris, myocardial infarction) within 6 months before enrollment;
• Within 6 months before study entry, the subject had a history of clinically significant arrhythmias or current abnormalities requiring antiarrhythmic treatment other than beta-blockers or digoxin and/or conduction drugs, excluding atrial fibrillation and paroxysmal supraventricular tachycardia;
• Left ventricular ejection fraction (LVEF) \<50% or congestive heart failure (New York Heart Association NYHA classification ≥3) at screening;
• Uncontrolled diabetes (glycosylated hemoglobin\>8%), uncontrolled hypertension (systolic blood pressure/diastolic blood pressure\>160mmHg/100mmHg while taking medication);
• Patients with active autoimmune diseases within 3 months before screening, such as systemic lupus erythematosus, who need to continue taking medication during the entire trial period;
• Other malignancies occurred within 5 years before enrollment, excluding cervical carcinoma in situ, skin squamous cell carcinoma, or basal cell carcinoma that had been treated with radical cure;
• Have a known symptomatic central nervous system (CNS) disease;
• Tumor cells infiltrate the central nervous system, and tumor cells are detected in the cerebrospinal fluid or the tumor is detected by cranial imaging;

Sponsors & Collaborators

• Shenzhen Celconta Life Science Co., Ltd.: lead

Study Sites (1)

AnYang Tumor Hospital

Anyang, Henan, 455000, China

RECRUITING

Central Study Contacts

Baozhong Li

CONTACT

13937238883; libaozhong99@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 17, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)