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Clinical Study of LY011 in the Treatment of Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

LY011

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression free survival（PFS）

Survival witouth observed progression at 2 years

Disease Control Rate（DCR）

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

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.

Overal survival （OS）

survival at 5 years

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

AEs according to CTCAE v 5.0.

Full Information

NCT ID

NCT04966143

First Posted

July 12, 2021

Last Updated

July 15, 2021

Sponsor

Shanghai Longyao Biotechnology Inc., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04966143

Brief Title

Clinical Study of LY011 in the Treatment of Advanced Pancreatic Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Anticipated)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Longyao Biotechnology Inc., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

LY011

Intervention Description

Targeting CLDN 18.2 Car-T injection

Primary Outcome Measure Information:

Title

Overall Response rate（ORR）

Description

Time Frame

1month

Secondary Outcome Measure Information:

Title

Progression free survival（PFS）

Description

Survival witouth observed progression at 2 years

Time Frame

1 years

Title

Disease Control Rate（DCR）

Description

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

Time Frame

1 years

Title

Duration of Response (DOR）

Description

Time Frame

1 years

Title

Overal survival （OS）

Description

survival at 5 years

Time Frame

5 years

Title

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

Description

AEs according to CTCAE v 5.0.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

The Affiliated Hospital of Xuzhou Medical University

City

Xuzhou

State/Province

Jiangsu

ZIP/Postal Code

221000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bin Liu

Phone

0516-85802369

xyfyll2297@163.com

First Name & Middle Initial & Last Name & Degree

Bin Liu

First Name & Middle Initial & Last Name & Degree

Wenxing Zhao

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of LY011 in the Treatment of Advanced Pancreatic Cancer

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