- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890198
A Phase 1 Study of LCAR-C182A Cells in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma
June 30, 2020 updated by: First Affiliated Hospital Xi'an Jiaotong University
A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C182A, an Anti-Claudin18.2 CAR-T Cell Therapy in Patients With Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma
This is an open label, single center, single arm phase 1 study to evaluate the safety , tolerability, pharmacokinetics and efficacy and immunogenicity of LCAR-C182A cells targeting Claudin18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Early 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
-
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Shanxi
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Xi'an, Shanxi, China, 710004
- The First Affiliated Hospital of Xian Jiaotong University
-
-
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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the subject has fully understood the possible risks and benefits of participating in this study, and has signed informed consent form (ICF);
- Age 18-75 years;
- Histologically confirmed unresectable advanced gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) or advanced pancreatic ductal carcinoma;
- Claudin18.2 positive by immunohistochemistry;
- Previously accepted the recommendations of the national comprehensive cancer network (NCCN 2019 V1) or the gastric cancer guidelines of the cooperative professional committee on clinical oncology (CSCO 2018 V1) of the Chinese anti-cancer association, or the standard treatment regimen considered to be equivalent by the investigator;
- Pancreatic cancer: ≥1 line standard chemotherapy, or regimens considered equivalent by the investigator, have recently failed or cannot be tolerated in the first line;
- By CT scan or MRI, patients with a measurable lesion ≥1cm or a single lymph node with a short diameter ≥1.5cm (RECIST 1.1) are required to obtain permission from the principal investigator if the lesion is measurable, i.e. the target lesion is lymph node metastasis;
- ECOG 0 ~ 1;
- expected survival period≥ 3 months;
- blood routine was in line with the certain standards;
- blood biochemical test meets the certain criteria;
- blood pregnancy test of women of child-bearing age was negative;
Exclusion Criteria:
- has received CAR-T therapy targeting any target.
- ever received any treatment targeting Claudin18.2.
- brain metastasis with central nervous system symptoms;
- pregnant or lactating women;
- uncontrolled diabetes;
- Oxygen absorption is required to maintain adequate blood oxygen saturation;
- Patients with pyloric obstruction, gastric perforation, partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved after active treatment;
- Hepatic disease;Chronic hepatitis infection with HBV/HCV;
- Seropositive for human immunodeficiency virus (HIV);
- Any active autoimmune disease or history of autoimmune disease;
- have obvious bleeding tendency, such as gastrointestinal bleeding, coagulation dysfunction, and hypersplenism;
- unstable angina within the past 6 months, symptomatic congestive heart failure or myocardial infarction;
- severe uncontrolled arrhythmias;Left ventricular ejection fraction <50%;
- activity requiring parenteral antibiotics or uncontrolled infection;There is evidence of severe active viral, bacterial or uncontrolled systemic fungal infection
- other malignancies in the past 5 years except for non-melanoma skin cancer or in-situ cervical cancer;
- chronic diseases treated with steroids or other immunosuppressive agents;
- Concurrent use of hematopoietic growth factor;
- Concurrent use of anticancer drugs or therapy (except radiotherapy for pain relief, etc., for non-target lesions);
- Concurrent investigational treatment;
- Have undergone chemotherapy, radiotherapy, or other experimental treatment within 4 weeks prior to apheresis
- stroke or convulsion within 6 months before signing ICF;
- Have received any live, attenuated vaccine within 4 weeks prior to apheresis;
- Have underwent major surgical operation within 2 weeks prior to apheresis, or anticipate to undergo a major surgical operation during the study process or within 2 weeks posterior to study treatment (with the exception of anticipated local anesthesia surgery)
- Allergic to the study drug expient and related expients (including but not limited to DMSO and dextran 40), or allergic to other immunotherapy and related drugs
- Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol
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: chimeric Antigen Receptor T cell
LCAR-C182A Cells
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Patients receive fludarabine (3×300 mg/ m^2) and cyclophosphamide (3×30 mg/m^2) IV on days -5 to-3, and then Patients receive CAR-T cells.
PS:The specific dose of fludarabine and cyclophosphamide is adjusted according to the individual condition of the subject and the judgment of the investigator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: 90 days post infusion
|
An adverse event is any untoward medical event that occurs in a participant administered an investigational product,and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
90 days post infusion
|
MTD)/ RP2D regimen finding
Time Frame: 90 days post infusion
|
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
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90 days post infusion
|
Transgene Levels of LCAR-C182A CAR-T Cells
Time Frame: 2 years post infusion
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Transgene Levels of LCAR-C182A CAR-T Cells using sensitive assay methods will be assessed
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2 years post infusion
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Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
Time Frame: 2 years post infusion
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Venous blood samples will be collected for measurement of CAR-T positive cellular concentration
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2 years post infusion
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Systemic Cytokine Concentrations
Time Frame: 2 years post infusion
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Serum cytokine concentrations such as IL-2, IL-6, IL-8, 1L-10, TNF-α, IFN-γ will be measured for biomarker assessment
|
2 years post infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) after administration
Time Frame: 2 years post infusion
|
The ORR is defined as the proportion of patients with complete or partial response according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
|
2 years post infusion
|
Duration of remission (DOR) after administration
Time Frame: 2 years post infusion
|
The DOR is defined as the time between the initial onset of complete or partial remission and the onset of disease progression in patients with objective remission according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
|
2 years post infusion
|
Progress Free Survival (PFS) after administration
Time Frame: 2 years post infusion
|
The PFS is defined as the Time from enrollment until disease progression or death according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
|
2 years post infusion
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Overall Survival (OS) after administration
Time Frame: 2 years post infusion
|
The OS is defined as Time from enrollment until death from any cause according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
|
2 years post infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Enxiao Li, MD,PhD, First Affiliated Hospital Xi'an Jiaotong University
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)
April 22, 2019
Primary Completion (Actual)
March 6, 2020
Study Completion (Actual)
March 6, 2020
Study Registration Dates
First Submitted
March 17, 2019
First Submitted That Met QC Criteria
March 24, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
July 2, 2020
Last Update Submitted That Met QC Criteria
June 30, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MO-GPC01
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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