Clinical Study Of LY011 In The Treatment Of Advanced Pancreatic Cancer

Study Overview

Clinical Study of LY011 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.

N/A

Pancreatic Cancer

BIOLOGICAL: LY011

LY011C1001

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
First Submitted 2021-07-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-07-15
First Submitted that Met QC Criteria 2021-07-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-07-19
First Posted (ACTUAL) 2021-07-19	Results First Posted N/A	Last Verified 2021-07

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/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment group	BIOLOGICAL: LY011 Targeting CLDN 18.2 Car-T injection

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment group

BIOLOGICAL: LY011

Targeting CLDN 18.2 Car-T injection

Primary Outcome Measures	Measure Description	Time Frame
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	1month

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival（PFS）	Survival witouth observed progression at 2 years	1 years
Disease Control Rate（DCR）	DCR (CR+PR+SD) by RECIST v1.1	1 years
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.	1 years
Overal survival （OS）	survival at 5 years	5 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	AEs according to CTCAE v 5.0.	1 year

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:

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;
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.

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;
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.

Collaborators and Investigators

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

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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Clinical Trial Record