Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer

April 16, 2023 updated by: Chongqing Precision Biotech Co., Ltd

Clinical Study of CEA-Targeted CAR-T Therapy in Patients With Relapsed and Refractory CEA+ Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

CEA is a classic tumor marker, especially in more than 80% of colorectal cancer patients. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of the digestive tract cells, and the CEA is expressed toward the cell cavity under physiological conditions to avoid recognition by CAR-T cells targeting CEA. This is a study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy,and obtain the recommended dose and infusion plan.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ning Li, MD
        • Sub-Investigator:
          • Yijie Ma, MM
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Donglin Wang, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. No gender limitation, age 18-75 years old (including boundary value);
  2. 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);
  3. There are measurable and assessable lesions: the diameter of the lesion under CT or MRI scan is greater than 0.5cm;
  4. The expected survival time is more than 12 weeks;
  5. KPS≥60 ;
  6. No serious mental disorders;

  7. The functions of important organs are basically normal:

    1. 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;
    2. Cardiac function: cardiac ultrasound indicates that the cardiac ejection fraction is ≥50%, and there is no obvious abnormality on the electrocardiogram;
    3. Renal function: serum creatinine and urea nitrogen ≤3.0 × ULN;
    4. Liver function: ALT and AST ≤5.0 × ULN; total bilirubin ≤3.0 × ULN;
    5. Blood oxygen saturation> 92%.
  8. There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation);
  9. There are no contraindications for apheresis or intravenous blood collection or other cell collection;
  10. 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.

Exclusion Criteria:

  1. Have received CAR-T treatment or other genetically modified cell treatment before screening;
  2. Participated in other clinical studies within 1 month before screening;
  3. 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;
  4. Have received live attenuated vaccine within 4 weeks before screening;
  5. Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;

  6. Suffering from any of the following heart diseases:

    1. New York Heart Association (NYHA) stage III or IV congestive heart failure;
    2. Myocardial infarction occurred or received coronary artery bypass graft (CABG) ≤6 months before enrollment;
    3. Clinically significant ventricular arrhythmias, or history of syncope of unknown cause (except for conditions caused by vasovagal or dehydration);
    4. Severe cardiac insufficiency, severe heart valve disease and other cardiovascular system diseases;
  7. There are active infections or uncontrollable infections requiring systemic treatment within 2 weeks before screening;
  8. Active autoimmune diseases;
  9. Suffering from chronic enteritis and / or intestinal obstruction;
  10. 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;
  11. 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;
  12. Women who are pregnant or breastfeeding;
  13. The situation that other researchers think is not suitable for participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CEA+ CAR-T
CAR-T cell reinfusion is carried out in 1~3 times
Biological: CEA CAR-T cells
CEA-CAR-T cells will be administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events that related to treatment
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The response rate of CEA CAR-T treatment in patients with relapse/refractory CEA+ Cancer that treatment by CEA CAR-T cells therapy
Time Frame: 6 months
The response rate of CEA CAR-T treatment will be recorded and assessed according to the irRECIST Version 1.1
6 months
Duration of Response (DOR) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
Time Frame: 2 years
DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause
2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
Time Frame: 2 years
PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression
2 years
Overall survival(OS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
Time Frame: 2 years
OS will be assessed from the first CAR-T cell infusion to death from any cause
2 years
Levels of CEA in Serum
Time Frame: 2 years
In vivo (Serum) quantity of CEA
2 years
Rate of CEA CAR-T cells in peripheral blood
Time Frame: 2 years
In vivo (peripheral blood) rate of CEA CAR-T cells were determined by means of flow cytometry
2 years
Quantity of CEA CAR copies in peripheral blood
Time Frame: 2 years
In vivo (peripheral blood) quantity of CEA CAR copies were determined by means of qPCR
2 years
Levels of IL-6 in Serum
Time Frame: 3 months
In vivo (Serum) quantity of IL-6
3 months
Levels of CRP in Serum
Time Frame: 3 months
In vivo (Serum) quantity of CRP
3 months

Collaborators and Investigators

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

Sponsor

Chongqing Precision Biotech Co., Ltd

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 Major Dates

Study Start (Actual)

February 20, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBC017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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