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Gastric CancerEarly Phase 1NCT03890198

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

A Early Phase 1 study testing LCAR-C182A cells in people with Gastric Cancer and Pancreatic Ductal Adenocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
LCAR-C182A cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteChina
Study dates
22 Apr 2019to 6 Mar 2020
Phase
Early 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
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  • 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；

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi’an, Shanxi, 710004

Other trials in China

About this study

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

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.

Being tested
LCAR-C182A cells
Keywords
Gastric cancer, Pancreatic Ductal Adenocarcinoma
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCAR-C182A cellsBiological

    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.

Study groups in NCT03890198
Study groupRoleWhat they receive
chimeric Antigen Receptor T cellExperimentalLCAR-C182A Cells
Receives: Biological: LCAR-C182A cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events

    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.

    Measured: 90 days post infusion

  2. MTD）/ RP2D regimen finding

    Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

    Measured: 90 days post infusion

  3. Transgene Levels of LCAR-C182A CAR-T Cells

    Transgene Levels of LCAR-C182A CAR-T Cells using sensitive assay methods will be assessed

    Measured: 2 years post infusion

  4. Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration

    Venous blood samples will be collected for measurement of CAR-T positive cellular concentration

    Measured: 2 years post infusion

  5. Systemic Cytokine Concentrations

    Serum cytokine concentrations such as IL-2, IL-6, IL-8, 1L-10, TNF-α, IFN-γ will be measured for biomarker assessment

    Measured: 2 years post infusion

Secondary outcomes (4)

  1. Overall response rate (ORR) after administration

    The ORR is defined as the proportion of patients with complete or partial response according to Response Evaluation Criteria In Solid Tumors（RECIST) criteria.

    Measured: 2 years post infusion

  2. Duration of remission (DOR) after administration

    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.

    Measured: 2 years post infusion

  3. Progress Free Survival (PFS) after administration

    The PFS is defined as the Time from enrollment until disease progression or death according to Response Evaluation Criteria In Solid Tumors（RECIST) criteria.

    Measured: 2 years post infusion

  4. Overall Survival (OS) after administration

    The OS is defined as Time from enrollment until death from any cause according to Response Evaluation Criteria In Solid Tumors（RECIST) criteria.

    Measured: 2 years post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2019
  2. Study start22 Apr 2019
  3. Primary completion6 Mar 2020
  4. Study completion6 Mar 2020

Why it stopped: the Preliminary data, progress of this study and the adjustment of the pipeline and strategy .

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03890198
Sponsor's protocol ID
MO-GPC01
Status last verified
Jun 2020
First submitted
17 Mar 2019
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LCAR-C182A cells in people with Gastric Cancer and Pancreatic Ductal Adenocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site 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 12 inclusion and 25 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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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: the Preliminary data, progress of this study and the adjustment of the pipeline and strategy .). 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?

Number of Participants With Adverse Events (time frame: 90 days post infusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03890198.

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 2 Jul 2020.

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