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A Phase 1 Study of LCAR-C182A Cells in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma

2019-04-22

2020-03-06

2020-03-06

2

Study Overview

A Phase 1 Study of LCAR-C182A Cells in the Treatment of 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.

N/A

  • Gastric Cancer
  • Pancreatic Ductal Adenocarcinoma
  • BIOLOGICAL: LCAR-C182A cells
  • MO-GPC01

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 Registration Dates Results Reporting Dates Study Record Updates

2019-03-17  

N/A  

2020-06-30  

2019-03-24  

N/A  

2020-07-02  

2019-03-26  

N/A  

2020-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: chimeric Antigen Receptor T cell

LCAR-C182A Cells

BIOLOGICAL: LCAR-C182A cells

  • 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 su
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of Participants With Adverse EventsAn 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 findingMaximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)90 days post infusion
Transgene Levels of LCAR-C182A CAR-T CellsTransgene Levels of LCAR-C182A CAR-T Cells using sensitive assay methods will be assessed2 years post infusion
Chimeric Antigen Receptor T (CAR-T) Positive Cell ConcentrationVenous blood samples will be collected for measurement of CAR-T positive cellular concentration2 years post infusion
Systemic Cytokine ConcentrationsSerum cytokine concentrations such as IL-2, IL-6, IL-8, 1L-10, TNF-α, IFN-γ will be measured for biomarker assessment2 years post infusion
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Overall response rate (ORR) after administrationThe 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 administrationThe 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 administrationThe 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
Overall Survival (OS) after administrationThe 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. the subject has fully understood the possible risks and benefits of participating in this study, and has signed informed consent form (ICF); 2. Age 18-75 years; 3. Histologically confirmed unresectable advanced gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) or advanced pancreatic ductal carcinoma; 4. Claudin18.2 positive by immunohistochemistry; 5. 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； 6. Pancreatic cancer: ≥1 line standard chemotherapy, or regimens considered equivalent by the investigator, have recently failed or cannot be tolerated in the first line； 7. 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； 8. ECOG 0 ~ 1; 9. expected survival period≥ 3 months； 10. blood routine was in line with the certain standards； 11. blood biochemical test meets the certain criteria； 12. blood pregnancy test of women of child-bearing age was negative；
    Exclusion Criteria:
    1. has received CAR-T therapy targeting any target. 2. ever received any treatment targeting Claudin18.2. 3. brain metastasis with central nervous system symptoms; 4. pregnant or lactating women; 5. uncontrolled diabetes; 6. Oxygen absorption is required to maintain adequate blood oxygen saturation; 7. Patients with pyloric obstruction, gastric perforation, partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved after active treatment; 8. Hepatic disease;Chronic hepatitis infection with HBV/HCV; 9. Seropositive for human immunodeficiency virus (HIV); 10. Any active autoimmune disease or history of autoimmune disease; 11. have obvious bleeding tendency, such as gastrointestinal bleeding, coagulation dysfunction, and hypersplenism; 12. unstable angina within the past 6 months, symptomatic congestive heart failure or myocardial infarction; 13. severe uncontrolled arrhythmias;Left ventricular ejection fraction <50%; 14. activity requiring parenteral antibiotics or uncontrolled infection;There is evidence of severe active viral, bacterial or uncontrolled systemic fungal infection 15. other malignancies in the past 5 years except for non-melanoma skin cancer or in-situ cervical cancer; 16. chronic diseases treated with steroids or other immunosuppressive agents; 17. Concurrent use of hematopoietic growth factor; 18. Concurrent use of anticancer drugs or therapy (except radiotherapy for pain relief, etc., for non-target lesions); 19. Concurrent investigational treatment; 20. Have undergone chemotherapy, radiotherapy, or other experimental treatment within 4 weeks prior to apheresis 21. stroke or convulsion within 6 months before signing ICF; 22. Have received any live, attenuated vaccine within 4 weeks prior to apheresis; 23. 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) 24. 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 25. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Nanjing Legend Biotech Co.
  • PRINCIPAL_INVESTIGATOR: Enxiao Li, MD,PhD, First Affiliated Hospital Xi'an Jiaotong University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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