A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors

NCT ID: NCT04467853

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2023-07-17

Brief Summary

This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced solid Tumors.

Detailed Description

This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced solid Tumors. Patients who meet the eligibility criteria will receive LCAR-C18S infusion. The study will include the following sequential phases: screening, pre-treatment , treatment and follow up

Conditions

Solid Tumors, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LCAR-C18S Cells

Each subject will receive LCAR-C18S Cells

Group Type: EXPERIMENTAL

LCAR-C18S cells

Intervention Type: BIOLOGICAL

Before treatment with LCAR-C18S cells, subjects will receive a conditioning regimen

Interventions

LCAR-C18S cells

Before treatment with LCAR-C18S cells, subjects will receive a conditioning regimen

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. The subjects have been fully informed of the possible risks and benefits of participating in the study and have signed the informed consent form;

2. Age 18-70 years;

3. Immunohistochemistry of tumor tissue samples indicates Claudin18.2 positive ;

4. Recurrent or metastatic advanced solid tumors (including advanced gastric cancers and non-gastric cancers) and have been failed to prior lines of systemic treatment

5. According to the RECIST v1.1, at least one measuable tumor lesion;

6. ECOG performance status score of 0-1;

7. Expected survival ≥ 3 months;

8. Subjects should have adequate organ functions before screening and treatment.

9. Women of childbearing age must have a negative blood pregnancy test; subjects of childbearing potential must use effective contraception for ≥ 1 year after the final study treatment.

Exclusion Criteria

1. Previous CAR-T cell therapy or other cell therapies or therapeutic tumor vaccination against any target;

2. Any previous therapy targeting Claudin18.2;

3. Prior antitumor therapy with insufficient washout period;

4. Pregnant or lactating women;

5. Brain metastases with central nervous system symptoms;

6. Uncontrolled diabetes;

7. Oxygen is required to maintain adequate blood oxygen saturation;

8. Gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention;

9. Clinically significant liver disorders (including liver cirrhosis, active viral hepatitis or other hepatitis);

10. HIV, Treponema pallidum or HCV serologically positive;

11. Severe underlying disease

12. New York Heart Association (NYHA) Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50%; unstable angina, myocardial infarction or coronary artery bypass grafting (CABG) in the past 6 months; history of severe non-ischemic cardiomyopathy; or severe uncontrolled arrhythmia;

13. Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Li

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Shanghai East Hospital

Shanghai, China/Shanghai, China

Shanghai Artemed Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

BM2L201910

Identifier Type: -

Identifier Source: org_study_id