Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 75

CAR-T therapy targeting EGFR and B7H3 for advanced lung and breast cancer

Official title: 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)

Run by Second Affiliated Hospital of Guangzhou Medical University · NCT05341492 · Data updated 2026-11-12

This study is testing a new CAR-T therapy for people with advanced lung cancer and triple-negative breast cancer to see if it helps them by targeting specific proteins in their tumors.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment30 (estimated)
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Academic / other
Drugs / interventionsCAR-T, CAR T, chemotherapy
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedMay 1, 2022
Main results expectedMay 1, 2030
Study endsMay 1, 2035
Registry record updatedJune 25, 2024
Trial IDNCT05341492 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 75 with advanced EGFR/B7H3-positive lung cancer or triple-negative breast cancer who have experienced treatment failure.

Probably not a fit

Patients with tumors that do not express EGFR or B7H3, or those with severe comorbidities affecting organ function, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a novel CAR-T therapy that targets both EGFR and B7H3 in patients with advanced lung cancer and triple-negative breast cancer. It is a single-arm, open-label exploratory study, meaning all participants will receive the treatment without a control group for comparison. The study aims to enroll patients who have confirmed positive expression of EGFR and B7H3 in their tumors and have measurable lesions. Participants will be monitored for treatment response and safety outcomes.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced lung and triple-negative breast cancer who currently have limited effective therapies.

How similar studies have gone: While CAR-T therapies have shown promise in hematological malignancies, this approach targeting solid tumors like lung and breast cancer is still novel and largely untested.

Who can join: the full rules

Show full inclusion / exclusion 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;
* 5\. Patients treated with radiotherapy or TKI within 2 weeks prior to infusion;
* 6\. Patients with active hepatitis B: HBV DNA\>1000IU/mL;
* 7\. HIV antibody, hepatitis C antibody, treponema pallidum antibody positive patients;
* 8\. 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);
* 11.Patients with central nervous primary tumor or central metastasis solid tumor (patients with stable treatment for more than 4 weeks after brain metastasis or patients with asymptomatic brain metastasis without treatment are excluded from this range), and patients with pericardial metastasis accompanied by large pericardial effusion.
* 12.Patients with a prior or concurrent second tumor, except in the following cases:

  * Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to enrollment);
  * Carcinoma in situ of cervical or breast cancer with no signs of recurrence for at least 3 years prior to study after curative treatment;
  * The primary malignancy has been completely resected and in complete remission for ≥5 years.
* 13.Pregnant or lactating women;
* 14.Patients who have a history of or currently have T-cell tumors;
* 15\. have active neuroautoimmune or inflammatory disorders (e.g. Guillian-Barre syndrome, AMyotrophic lateral sclerosis);
* 16.Other conditions, such as compliance, that the investigator considers should not be included in this clinical trial.

Where it's running

  • Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.