NCT04348643

Brief Summary

This is a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan.

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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2020

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

February 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2022

Enrollment Period

3.9 years

First QC Date

April 14, 2020

Last Update Submit

April 16, 2023

Conditions

Solid TumorLung CancerColorectal CancerLiver CancerPancreatic CancerGastric CancerBreast Cancer

Keywords

CAR-TSolid TumorLung CancerColorectal CancerLiver CancerPancreatic CancerGastric CancerBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Adverse events that related to treatment

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

    2 years

Secondary Outcomes (9)

  • The response rate of CEA CAR-T treatment in patients with relapse/refractory CEA+ Cancer that treatment by CEA CAR-T cells therapy

    6 months

  • Duration of Response (DOR) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer

    2 years

  • Progress-free survival(PFS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer

    2 years

  • Overall survival(OS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer

    2 years

  • Levels of CEA in Serum

    2 years

  • +4 more secondary outcomes

Study Arms (1)

CEA+ CAR-T

EXPERIMENTAL

CAR-T cell reinfusion is carried out in 1\~3 times

Biological: CEA CAR-T cells

Interventions

CEA CAR-T cellsBIOLOGICAL

CEA-CAR-T cells will be administered intravenously.

CEA+ CAR-T

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No gender limitation, age 18-75 years old (including boundary value);
  • Late, metastatic, or recurrent malignant tumors that have received at least first-line standard treatment failure (progressive or intolerable disease, such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment, and the tumor CEA positive expression (tumor CEA positive or serum CEA level\> 50ng / ml confirmed by histology or pathology);
  • There are measurable and assessable lesions: the diameter of the lesion under CT or MRI scan is greater than 0.5cm;
  • The expected survival time is more than 12 weeks;
  • KPS≥60 ;
  • No serious mental disorders;
  • The functions of important organs are basically normal:
  • Blood routine: white blood cells\> 2.0 × 10\^9 / L, neutrophils\> 0.8 × 10\^9 / L, lymphocytes\> 0.5 × 10\^9 / L, platelets\> 50 × 10\^9 / L, hemoglobin\> 90g / L;
  • Cardiac function: cardiac ultrasound indicates that the cardiac ejection fraction is ≥50%, and there is no obvious abnormality on the electrocardiogram;
  • Renal function: serum creatinine and urea nitrogen ≤3.0 × ULN;
  • Liver function: ALT and AST ≤5.0 × ULN; total bilirubin ≤3.0 × ULN;
  • Blood oxygen saturation\> 92%.
  • There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation);
  • There are no contraindications for apheresis or intravenous blood collection or other cell collection;
  • The patient or his guardian agrees to participate in this clinical trial and sign the ICF, indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the study.

You may not qualify if:

  • Have received CAR-T treatment or other genetically modified cell treatment before screening;
  • Participated in other clinical studies within 1 month before screening;
  • Received the following anti-tumor treatment before screening: received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except for those who have confirmed disease progression after treatment;
  • Have received live attenuated vaccine within 4 weeks before screening;
  • Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;
  • Suffering from any of the following heart diseases:
  • New York Heart Association (NYHA) stage III or IV congestive heart failure;
  • Myocardial infarction occurred or received coronary artery bypass graft (CABG) ≤6 months before enrollment;
  • Clinically significant ventricular arrhythmias, or history of syncope of unknown cause (except for conditions caused by vasovagal or dehydration);
  • Severe cardiac insufficiency, severe heart valve disease and other cardiovascular system diseases;
  • There are active infections or uncontrollable infections requiring systemic treatment within 2 weeks before screening;
  • Active autoimmune diseases;
  • Suffering from chronic enteritis and / or intestinal obstruction;
  • Suffering from other malignant tumors, in addition to fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
  • Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Henan Cancer Hospital

Henan, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsColorectal NeoplasmsLiver NeoplasmsPancreatic NeoplasmsStomach NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesStomach DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Zhi Yang, PhD

CONTACT

86-13206140093yangzhi@precision-biotech.com

Yingzi Zhang

CONTACT

86-18623351275yingzi6526@163.com

Study Design

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

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

February 20, 2020

Primary Completion

December 31, 2023

Study Completion

April 30, 2024

Last Updated

April 18, 2023

Record last verified: 2022-04

Locations

CN(2)