EGFR/ B7H3-positive Advanced Lung Cancer study: EGFR/B7H3 CAR-T
Official title EGFR/B7H3 CAR-T on Lung Cancer and Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT05341492
What this study is testing
What is EGFR/B7H3 CAR‑T?
An investigational cellular therapy being studied for EGFR/B7H3‑positive advanced lung cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe and effective the EGFR/B7H3 CAR‑T treatment is for these cancers.
- Who it's for
- Adults with advanced lung cancer or triple‑negative breast cancer that tests positive for EGFR and B7H3.
- What's involved
- Participants receive the CAR‑T cell therapy and have scheduled visits and tests to monitor safety and tumor response.
- Time commitment
- The study lasts several months, with multiple clinic visits and monitoring appointments throughout the treatment period.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1.All people or legal guardians must sign the informed consent form approved by the ethics committee in writing before starting any screening...
- 2.18 Years to 75 Years, Histologically or cytologically confirmed Routine treatment of patients with advanced lung cancer and triple-negative breast...
- 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 how well it works evaluation criteria, there should be at least one measurable lesion during...
- 5.Expected survival time ≥ 12 weeks;
You likely can't join if
- 1.Uncontrolled hypertension (\> 160/95), unstable coronary artery disease confirmed by uncontrolled arrhythmia, unstable angina pectoris...
- 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;
See the full eligibility criteria
- 1.All people 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 how well it works evaluation criteria, there should be at least one measurable lesion during screening period (results are available within one month prior to screening...
- 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...
- 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 (people 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
- 10.Women of childbearing age and all male people 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...
- 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)...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Guangzhou, Guangdong, China
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Guangzhou, Guangdong, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.