Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of XKDCT086 (iPD-1-Claudin18.2-CAR-T) in Claudin 18.2 Positive Advanced Solid Malignant Tumors: a Single Center, Single Arm, Dose-increasing Trial

NCT05952375 | Unknown

• 1 other identifier: XKDCT086
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assessing the safety and tolerability of XKDCT086 cells against recurrent or refractory solid tumors with Claudin18.2 positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting Claudin18.2.

Conditions

Gastric Cancer

Keywords

Chimeric Antigen

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE)

  o characterize the safety profile of XKDCT086 in patients with advanced solid tumor

  12 months

Study Arms (1)

XKDCT086 treatment for patients with Claudin18.2 target positivity

EXPERIMENTAL

Drug: XKDCT086 (chimeric antigen receptor T cell preparation targeting Claudin18.2) Dosage form: Cell suspension Dose: 30-50mL/bag Medication method: intravenous drip Frequency: Once

Drug: Chimeric antigen receptor T cell preparation targeting Claudin18.2

Interventions

Chimeric antigen receptor T cell preparation targeting Claudin18.2 DRUG

Chimeric antigen receptor T cell preparation targeting Claudin18.2

XKDCT086 treatment for patients with Claudin18.2 target positivity

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 range from 18 to 75 years old (including threshold), regardless of gender;
• \. Patients with advanced solid malignant tumors with positive expression of Claudin 18.2 (including but not limited to gastric cancer, esophageal gastric junction adenocarcinoma, and esophageal adenocarcinoma); And after sufficient treatment, the condition cannot be completely relieved or continue to progress;;
• \. At least one measurable lesion (non lymph node lesion with a length diameter of ≥ 10mm and lymph node lesion with a short diameter of ≥ 15mm) using the RECIST 1.1 standard;
• \. Expected survival time ≥ 12 weeks;
• \. ECOG score 0-1 points;
• \. The laboratory test values conducted for screening must meet the following standards:
• Blood routine examination:
• WBC ≥ 3.0 × 10\^9/L
• ANC ≥ 1.5 × 10\^9/L
• HB ≥ 80g/L (no blood transfusion received within 2 weeks)
• PLT ≥ 100 × 10\^9/L
• Blood biochemical examination:
• ALT and AST ≤ 2.5 × ULN (≤ 5 if accompanied by liver metastasis) × ULN
• ALB ≥ 30g/L
• Serum creatinine ≤ 1.5 × ULN or GFR\>50mL/min (GFR=\[(140 age) × weight × (0.85 female)\]/(72 × Scr)

You may not qualify if:

• \. Pregnant or lactating women;
• \. Active hepatitis B, hepatitis C or other infectious diseases (syphilis, HIV)
• \. Any active infection that requires antibiotic treatment;
• \. Have received any immune cell therapy within one year;
• \. Have received Targeted therapy drugs of Claudin18.2 in the past;
• \. Inoculate with live vaccines or attenuated live vaccines within 4 weeks before single collection;
• \. Allergic or intolerant to the research drug Tocilizumab, fludarabine, Cyclophosphamide and other anti drenching drugs selected by the researcher;
• \. Uncontrolled cardio cerebral Vascular disease, such as heart failure or others, existed within 6 months before enrollment;
• \. Within the 6 months prior to enrollment in the study, the subjects had a clinically significant history of arrhythmia or were currently in need of treatment β Abnormalities of antiarrhythmic therapy other than receptor blockers or Digoxin and/or conduction drugs, except atrial fibrillation and paroxysmal supraventricular tachycardia;
• \. Left ventricular Ejection fraction (LVEF)\<50% at screening;
• \. Patients with active autoimmune diseases, such as systemic lupus erythematosus, within the first 3 months of screening; Those who require continuous medication throughout the entire trial period;
• \. Before single collection, oxygen inhalation is required to maintain a fingertip blood oxygen saturation of ≥ 95%;
• \. Other malignant tumors occurred within 5 years before enrollment, except for cervical Carcinoma in situ, Cutaneous squamous-cell carcinoma or Basal-cell carcinoma which had been treated for radical treatment before;
• \. Suffering from known symptomatic central nervous system (CNS) diseases;
• \. Surgery was performed within 2 weeks prior to single collection and the researchers believe it may affect patient safety;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• YU cao, MD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YU cao, MD

CONTACT

18661809090; caoyu1767@126.com

YU cao

CONTACT

18661809090; caoyu1767@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: March 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

CN (1)