- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04467853
A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors
August 11, 2023 updated by: Jin Li, Shanghai East Hospital
A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C18S, an CAR-T Cell Therapy Targeting Claudin18.2 in Patients With Advanced Solid Tumors
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Anhui
-
Hefei, Anhui, China
- Anhui Provincial Hospital
-
-
China/Shanghai
-
Shanghai, China/Shanghai, China, 200126
- Shanghai East Hospital
-
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Shanghai
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Shanghai, Shanghai, China
- Shanghai Artemed Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The subjects have been fully informed of the possible risks and benefits of participating in the study and have signed the informed consent form;
- Age 18-70 years;
- Immunohistochemistry of tumor tissue samples indicates Claudin18.2 positive ;
- Recurrent or metastatic advanced solid tumors (including advanced gastric cancers and non-gastric cancers) and have been failed to prior lines of systemic treatment
- According to the RECIST v1.1, at least one measuable tumor lesion;
- ECOG performance status score of 0-1;
- Expected survival ≥ 3 months;
- Subjects should have adequate organ functions before screening and treatment.
- 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:
- Previous CAR-T cell therapy or other cell therapies or therapeutic tumor vaccination against any target;
- Any previous therapy targeting Claudin18.2;
- Prior antitumor therapy with insufficient washout period;
- Pregnant or lactating women;
- Brain metastases with central nervous system symptoms;
- Uncontrolled diabetes;
- Oxygen is required to maintain adequate blood oxygen saturation;
- Gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention;
- Clinically significant liver disorders (including liver cirrhosis, active viral hepatitis or other hepatitis);
- HIV, Treponema pallidum or HCV serologically positive;
- Severe underlying disease
- 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;
- Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LCAR-C18S Cells
Each subject will receive LCAR-C18S Cells
|
Before treatment with LCAR-C18S cells, subjects will receive a conditioning regimen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs),Safety
Time Frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
|
Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs),Safety
|
Minimum 2 years after LCAR-C18S infusion (Day 1)
|
To determine the recommended dose of the phase Ⅱ trial of this cell therapy (RP2D)
Time Frame: 90 days post infusion
|
To determine the recommended dose of the phase Ⅱ trial of this cell therapy (RP2D)
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90 days post infusion
|
Pharmacokinetic (PK) parameters
Time Frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
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Blood samples will be collected for determination of cellular concentrations and transgenic levels of serum LCAR-C18S for pharmacokinetic analysis
|
Minimum 2 years after LCAR-C18S infusion (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) after administration
Time Frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
|
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LCAR-C18S cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1 only
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Minimum 2 years after LCAR-C18S infusion (Day 1)
|
Progress Free Survival (PFS) after administration
Time Frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
|
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-C18S to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first
|
Minimum 2 years after LCAR-C18S infusion (Day 1)
|
Overall Survival (OS) after administration
Time Frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
|
Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-C18S to death of the subject.
|
Minimum 2 years after LCAR-C18S infusion (Day 1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jin Li, MD, PhD, Shanghai East Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2020
Primary Completion (Actual)
July 17, 2023
Study Completion (Actual)
July 17, 2023
Study Registration Dates
First Submitted
July 1, 2020
First Submitted That Met QC Criteria
July 10, 2020
First Posted (Actual)
July 13, 2020
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 11, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BM2L201910
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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