A Single-arm, Open, Exploratory Clinical Study Evaluating the Safety and Efficacy of EGFR/B7H3 CAR-T in Patients With EGFR/ B7H3-positive Advanced Solid Tumors (Lung and Triple-negative Breast Cancer)

Second Affiliated Hospital of Guangzhou Medical University1 site in 1 country30 target enrollmentMay 1, 2022

ConditionsEGFR/ B7H3-positive Advanced Lung Cancer EGFR/ B7H3-positive Advanced Triple-negative Breast Cancer

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: EGFR/ B7H3-positive Advanced Lung Cancer
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Enrollment: 30
Locations: 1
Primary Endpoint: Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a single-arm, open, exploratory clinical study to evaluate the safety and efficacy of EGFR/B7H3 CAR-T in patients with EGFR/ B7H3-positive advanced solid tumors (lung cancer and triple-negative breast cancer)

Registry

clinicaltrials.gov

Start Date

May 1, 2022

End Date

May 1, 2035

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.All subjects or legal guardians must sign the informed consent form approved by the ethics committee in writing before starting any screening procedure;
•2.18 Years to 75 Years, Histologically or cytologically confirmed Routine treatment of patients with advanced lung cancer and triple-negative breast cancer(Including TKI treatment failure patients);
•3.EGFR/B7H3 expression was confirmed positive in tumor site by immunohistochemical test within 3 months before signing the informed consent form;
•4.According to RECIST version 1.1 of solid tumor efficacy evaluation criteria, there should be at least one measurable lesion during screening period (results are available within one month prior to screening period) ;
•5.Expected survival time ≥ 12 weeks;
•6.The Eastern oncology group strength status score (ECOG) was 0-1;
•7.Adequate organ function: alanine aminotransferase, aspartate aminotransferase (ALT, AST) \< 3 times of normal value, total bilirubin (TBiL) \< 1.5 times of normal value, serum creatinine (SCr) \< 1.5 times of normal value;
•8.The hemodynamics determined by echocardiography or multichannel radionuclide angiography(MUGA) are stable and the left ventricular ejection fraction (LVEF)≥50%;
•9.Have sufficient bone marrow reserves (subjects can meet this requirement through blood transfusion), defined as: The number of white blood cells should not be less than 1 × 10\^9/L;Platelet≥100 x 10\^9/L; Hemoglobin ≥100 g/L;
•10.Women of childbearing age and all male subjects must agree to use effective contraceptive methods for at least 52 weeks after EGFR CAR-T infusion, and until two consecutive PCR tests show that CAR-T cells are no longer present in the body.

Exclusion Criteria

•1.Uncontrolled hypertension (\> 160/95), unstable coronary artery disease confirmed by uncontrolled arrhythmia, unstable angina pectoris, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months prior to cell infusion;
•2.Patients with severe liver and kidney dysfunction or consciousness disorder;
•3.Patients who received antitumor chemotherapy other than lymphocyte clearance chemotherapy within 14 days prior to CAR T infusion;
•4.Patients who received other study drugs within 14 days prior to infusion;
•Patients treated with radiotherapy or TKI within 2 weeks prior to infusion;
•Patients with active hepatitis B: HBV DNA\>1000IU/mL;
•HIV antibody, hepatitis C antibody, treponema pallidum antibody positive patients;
•Sputum smears and patients who test positive for T cells of tuberculosis infection
•9.Patients with interstitial lung disease or pneumonia;
•10.patients with uncontrolled acute life-threatening bacterial, viral or fungal infection (e.g. positive blood culture ≤72 hours prior to infusion);