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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890198
Recruitment Status : Terminated (the Preliminary data, progress of this study and the adjustment of the pipeline and strategy .)
First Posted : March 26, 2019
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Nanjing Legend Biotech Co.
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Pancreatic Ductal Adenocarcinoma Biological: LCAR-C182A cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 22, 2019
Actual Primary Completion Date : March 6, 2020
Actual Study Completion Date : March 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/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 subject and the judgment of the investigator.




Primary Outcome Measures :
  1. 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.

  2. MTD)/ RP2D regimen finding [ Time Frame: 90 days post infusion ]
    Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

  3. Transgene Levels of LCAR-C182A CAR-T Cells [ Time Frame: 2 years post infusion ]
    Transgene Levels of LCAR-C182A CAR-T Cells using sensitive assay methods will be assessed

  4. Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration [ Time Frame: 2 years post infusion ]
    Venous blood samples will be collected for measurement of CAR-T positive cellular concentration

  5. Systemic Cytokine Concentrations [ Time Frame: 2 years post infusion ]
    Serum cytokine concentrations such as IL-2, IL-6, IL-8, 1L-10, TNF-α, IFN-γ will be measured for biomarker assessment


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890198


Locations
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China, Shanxi
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shanxi, China, 710004
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Nanjing Legend Biotech Co.
Investigators
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Principal Investigator: Enxiao Li, MD,PhD First Affiliated Hospital Xi'an Jiaotong University
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03890198    
Other Study ID Numbers: MO-GPC01
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Gastric cancer
Pancreatic Ductal Adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases