Solid Tumors, AdultPhase 1NCT04467853
A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors
A Phase 1 study testing LCAR-C18S cells in people with Solid Tumors, Adult, run by Shanghai East Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumors, Adult
- What is being tested?
- LCAR-C18S cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesChina
- Study dates
- 21 Sep 2020to 17 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Anhui Provincial Hospital
Hefei, Anhui
Shanghai East Hospital
Shanghai, China/Shanghai, 200126
Shanghai Artemed Hospital
Shanghai, Shanghai Municipality
About this study
Official title: 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.
Read the 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
- Being tested
- LCAR-C18S cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCAR-C18S cellsBiological
Before treatment with LCAR-C18S cells, subjects will receive a conditioning regimen
| Study group | Role | What they receive |
|---|---|---|
| LCAR-C18S Cells | Experimental | Each subject will receive LCAR-C18S Cells Receives: Biological: LCAR-C18S cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs),Safety
Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs),Safety
Measured: Minimum 2 years after LCAR-C18S infusion (Day 1)
To determine the recommended dose of the phase Ⅱ trial of this cell therapy (RP2D)
To determine the recommended dose of the phase Ⅱ trial of this cell therapy (RP2D)
Measured: 90 days post infusion
Pharmacokinetic (PK) parameters
Blood samples will be collected for determination of cellular concentrations and transgenic levels of serum LCAR-C18S for pharmacokinetic analysis
Measured: Minimum 2 years after LCAR-C18S infusion (Day 1)
Secondary outcomes (3)
Overall response rate (ORR) after administration
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
Measured: Minimum 2 years after LCAR-C18S infusion (Day 1)
Progress Free Survival (PFS) after administration
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
Measured: Minimum 2 years after LCAR-C18S infusion (Day 1)
Overall Survival (OS) after administration
Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-C18S to death of the subject.
Measured: Minimum 2 years after LCAR-C18S infusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start21 Sep 2020
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Why it stopped: Both the sponsors and collaborator are considering terminating the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Responsible party
- Principal investigator, Jin Li, Shanghai East Hospital
- Investigators
- Jin Li, MD, PhD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467853
- Sponsor's protocol ID
- BM2L201910
- Status last verified
- Aug 2023
- First submitted
- 1 Jul 2020
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04467853
- Acronym / sponsor ID
- BM2L201910
- Conditions
- Solid Tumors, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Both the sponsors and collaborator are considering terminating the study
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCAR-C18S Cells | Experimental | Biological: LCAR-C18S cellsEach subject will receive LCAR-C18S Cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCAR-C18S cellsBefore treatment with LCAR-C18S cells, subjects will receive a conditioning regimen | Biological | LCAR-C18S Cells |
Primary outcome
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
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)
Pharmacokinetic (PK) parameters
Time frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
Blood samples will be collected for determination of cellular concentrations and transgenic levels of serum LCAR-C18S for pharmacokinetic analysis
3 secondary outcomes
Overall response rate (ORR) after administration
Time frame: 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)
Overall Survival (OS) after administration
Time frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
Results and safety
The study was stopped early (reason given: Both the sponsors and collaborator are considering terminating the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors, Adult
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruiting
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingEarly Phase 1
Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Li, MD, PhD principal investigator
Shanghai East Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LCAR-C18S cells in people with Solid Tumors, Adult, run by Shanghai East Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Both the sponsors and collaborator are considering terminating the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.