NCT04966143

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P75+ for early_phase_1 pancreatic-cancer

Timeline
Completed

Started Aug 2021

Typical duration for early_phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

July 12, 2021

Last Update Submit

July 15, 2021

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (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

    1month

Secondary Outcomes (5)

  • Progression free survival（PFS）

    1 years

  • Disease Control Rate（DCR）

    1 years

  • Duration of Response (DOR）

    1 years

  • Overal survival （OS）

    5 years

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

    1 year

Study Arms (1)

Treatment group

EXPERIMENTAL
Biological: LY011

Interventions

LY011BIOLOGICAL

Targeting CLDN 18.2 Car-T injection

Treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 19, 2021

Study Start

August 1, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2024

Last Updated

July 19, 2021

Record last verified: 2021-07

Locations

CN(1)