A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer (CRC)

NCT04513431 | Unknown Early Phase 1

• 1 other identifier: RJBY_anti-CEA CAR-T_CRC01
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Conditions

Stage III Colorectal Cancer; Colorectal Cancer Liver Metastasis

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)

  4 weeks

Secondary Outcomes (3)

• Survival time of Anti-CEA CAR T cells in vivo.

  3 months

• Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells

  6 months

• Maximum tolerated dose (MTD) of CEA targeted CAR T cells

  4 weeks

Study Arms (1)

Colorectal cancer

EXPERIMENTAL

Colorectal cancer treated with T cells modified with Anti-CEA-CAR T.

Biological: Anti-CEA-CAR T

Interventions

Anti-CEA-CAR T BIOLOGICAL

T cells modified with CEA targeted chimeric antigen receptor.

Colorectal cancer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CEA positive T4/N2 high-risk stage-Ⅲ colorectal cancer after surgery or patients with colorectal cancer liver metastasis after R0 surgery;
• Patients whose serum CEA ≥11 ng/mL;
• Life expectancy ≥ 3 months;
• PS score 0-2, KPS score ≥60;
• \>3 CTC/7.5 mL blood sample;
• Patients who plan to use XELOX chemotherapy after surgery;
• Patients must have adequate organ function , such as NYHA heart function classification grade III or higher, no severe anemia, hypoxia; liver function: total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN when liver metastasis), ALT≤2.5×ULN, AST≤2.5×ULN (ALT or/and AST≤5×ULN when liver metastasis); renal function: blood creatinine ≤1.5 × ULN and creatinine clearance ≥50 mL/min, only when blood creatinine ≤ Calculate the creatinine clearance rate when 1.5 × ULN;
• Sufficient peripheral blood can be obtained through peripheral veins without contraindications to apheresis;
• Patients of childbearing age have no birth plans and take effective contraceptive measures during the study period and within 1 year after the study.

You may not qualify if:

• Patients who have a history of severe central nervous system disease;
• Other organ metastases except liver;
• Patients who have non malignant diseases, including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive respiratory diseases;
• Patients received car-t or other gene modified T cell therapy previously;
• Patients who plan to use other targeted anti-tumor drugs;
• Patients who participated in other clinical studies within 30 days before screening or planned to participate in other clinical studies during the study period;
• Patients who have syphilis or HIV / HBV / HCV / HPV / EBV / CMV infection ; HBV-DNA copy number ≥ 1 × 10 \^ 5 copies / ml is required for HBV seropositive patients;
• Patients who have uncontrollable systemic infectious diseases;
• Patients who have multiple malignant tumor;
• Patients who received or may need Chinese herbal medicine, systemic glucocorticoid or other immunosuppressants within 2 weeks before enrollment;
• Patient who are pregnancy and lactating;
• Patients who have severe gastroduodenal ulcer, ulcerative colitis and other intestinal inflammation;

Sponsors & Collaborators

• Ruijin Hospital: lead
• HuaDao (Shanghai) Biomedical Co., Ltd.: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ren Zhao, Medical PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Mei Wang, Medical PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Chen xianze, Medical PhD

  Ruijin Hospital

  STUDY CHAIR

• Liu Kun, Medical PhD

  Ruijin Hospital

  STUDY CHAIR

• Shi Yiqing, Medical PhD

  Ruijin Hospital

  STUDY CHAIR

• Wang Chen, Medical PhD

  Ruijin Hospital

  STUDY CHAIR

• He Qianyun, Medical PhD

  Ruijin Hospital

  STUDY CHAIR

• Mao Dongliang, Medical PhD

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Mei Wang, Medical PhD

CONTACT

+86-13601810867; 13601810867@163.com

Lin Tian, Medical PhD

CONTACT

13651760950; lin.tian@huadaocart.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oncology

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 14, 2020
• Study Start: August 30, 2020
• Primary Completion: March 30, 2021
• Study Completion: August 30, 2023
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share