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Pancreatic CancerEarly Phase 1NCT04966143

Clinical Study of LY011 in the Treatment of Advanced Pancreatic Cancer

A Early Phase 1 study testing LY011 in people with Pancreatic Cancer, run by Shanghai Longyao Biotechnology Inc., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

CLDN 18.2 chimeric antigen receptor T cells Clinical research plan for the treatment of recurrent or refractory pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
LY011
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Aug 2021to 1 Aug 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • They were 18 to 70 years old, male or female;
  • Definitive diagnosis is recurrent or refractory pancreatic cancer;
  • Claudin 18.2 IHC staining was positive in tumor tissues;
  • Life expectancy > 12 weeks;
  • According to RECIST 1.1, there was at least one measurable tumor target;
  • ECoG scores at screening, 24 hours before puncture and baseline (before treatment) were 0-1;
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  • Adequate organ function;
  • Women of childbearing age with negative pregnancy test or male subjects must take effective and reliable contraceptive methods until 30 days after the end of treatment;
  • Have enough understanding ability to voluntarily sign informed consent to participate in clinical research.

Who cannot join

  • Pregnant or lactating women;
  • HIV, syphilis spirochete or HCV serological positive;
  • Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection (HBsAg positive, HBcAb positive, HBV DNA positive);
  • The subjects were judged as clinically significant thyroid dysfunction by the investigators (serum thyroid hormone determination TT4, TT3, FT3, FT4, serum thyroid stimulating hormone TSH) and were not suitable to participate in this study;
  • The side effects of the patients were not recovered to CTCAE ≤ 1;
  • Subjects who are currently using steroids all over the body within 7 days before the pregnancy is taken out; Inhaled steroids are not excluded in the near future or in the near future;
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  • Previous allergies to immunotherapy and related drugs, severe allergies or allergies;
  • T cells (including car-t, tcr-t) that have been modified by chimeric antigen receptor have been reported.
  • The subjects had untreated or symptomatic brain metastasis;
  • The subjects had heart disease which needed treatment or after treatment, hypertension was out of control (blood pressure > 160 mmHg / 100 mmHg);
  • Subjects with or waiting for organ transplantation history;
  • No other serious disease may limit subjects' participation in this trial
  • The researchers assessed that subjects were unable or unwilling to comply with the requirements of the study program.
  • It has abnormal signs of central nervous system diseases or abnormal results of nervous system detection, which has clinical significance;
  • Subjects currently or had other malignant tumors that could not be cured within 3 years, except for in situ cervical or skin basal cell carcinoma.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

    Bin Liu, 0516-85802369, xyfyll2297@163.com

    Bin Liu

    Recruiting

Other trials in China

About this study

Official title: A Study of CLDN18.2 Chimeric Antigen Receptor T Cells in the Treatment of Advanced Pancreatic Cancer

CLDN 18.2 chimeric antigen receptor T cells Clinical research plan for the treatment of recurrent or refractory pancreatic cancer.

Being tested
LY011
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • LY011Biological

    Targeting CLDN 18.2 Car-T injection

Study groups in NCT04966143
Study groupRoleWhat they receive
Treatment groupExperimentalNot described
Receives: Biological: LY011

What is being measured

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

  1. Overall Response rate（ORR）

    the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

    Measured: 1month

Secondary outcomes (5)

  1. Progression free survival（PFS）

    Survival witouth observed progression at 2 years

    Measured: 1 years

  2. Disease Control Rate（DCR）

    DCR (CR+PR+SD) by RECIST v1.1

    Measured: 1 years

  3. Duration of Response (DOR）

    DOR was defined as the time from the first documented a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) to progressive disease (PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.

    Measured: 1 years

  4. Overal survival （OS）

    survival at 5 years

    Measured: 5 years

  5. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    AEs according to CTCAE v 5.0.

    Measured: 1 year

Timeline

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

  1. First posted19 Jul 2021
  2. Study start1 Aug 2021 (estimated)
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion1 Aug 2024 (estimated)

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04966143
Sponsor's protocol ID
LY011C1001
Status last verified
Jul 2021
First submitted
12 Jul 2021
Last updated
19 Jul 2021
Results posted
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 LY011 in people with Pancreatic Cancer, run by Shanghai Longyao Biotechnology Inc., Ltd. 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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response rate（ORR） (time frame: 1month). 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 NCT04966143.

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 19 Jul 2021.

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