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)

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Zhang Zhenfeng, PhD
zhangzhf@gzhmu.edu.cn
+862039195965
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2035-05-01
Participants
Target number of participants: 30
Treatments
Experimental: Treatment
Patients will receive 2\*10e6/kgCAR-T cells.
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov

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