A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy forCEA-positive Advanced/Metastatic Malignant Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years old, male or female;

• Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer;

• After receiving at least second-line standard treatment failure (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;

• Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); , the positive rate ≥ 10%), the serum CEA of the patient is required to exceed 10ug/L.

• At least one assessable lesion according to RECIST 1.1 criteria;

• ECOG score 0-2 points;

• No serious mental disorder;

• Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions:

∙ Blood routine: white blood cells\>3.0×10\^9/L, neutrophils\>0.8×10\^9/L, lymphocytes cells\>0.5×10\^9/L, platelets\>75×10\^9/L, hemoglobin\>80g/L;

‣ Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;

‣ Renal function: serum creatinine≤2.0×ULN;

‣ Liver function: ALT and AST ≤3.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤5.0×ULN);

‣ Total bilirubin≤3.0×ULN;

‣ Oxygen saturation ≥95% in non-oxygen state.

• Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;

⁃ Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);

⁃ The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.

Locations
Other Locations
China
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Contact Information
Primary
Fei Li, M.D
691058841@qq.com
13970038386
Time Frame
Start Date: 2023-09-30
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 36
Treatments
Experimental: Intravenous of CEA-targeted CAR-T
Infusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg
Experimental: intraperitoneal injection of CEA-targeted CAR-T
Infusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg
Sponsors
Collaborators: The First Affiliated Hospital of Nanchang University
Leads: Chongqing Precision Biotech Co., Ltd

This content was sourced from clinicaltrials.gov

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