Malignant neoplasm of skin
Conditions
Interventions
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Various types of solid tumors with high expression of B7H3 in tumor tissues were confirmed by histological /cytological examination, and there was no standard treatment or standardTumor patients who have failed to respond to quasi therapy or are not suitable for standard treatment; 2) There must be measurable or assessable lesions that meet RECIST (v.1.1) criteria; 3) Patients should have no serious hematopoietic dysfunction, have good organ function, and meet all the following laboratory tests before enrollment: Absolute neutrophil count (ANC) >= 1.5x10^9/L, platelet (PLT) >= 70x10^9/L, hemoglobin (Hb) >= 90g/L; ALT and AST = 60 mL/min. 4) The physical condition score ECOG <= 2; 5) Highly sensitive serum pregnancy in fertile women at screening time and before initial treatment with cyclophosphamide and fludarabine. The pregnancy test (beta-human chorionic gonadotropin [ß-HCG]) must be negative; 6) The venous access required for collection can be established without contraindications to white blood cell collection; 7) Voluntarily enrolled, signed the informed consent, followed the trial treatment plan and visit plan.
Exclusion criteria
Exclusion criteria: 1) Patients with an expected survival of less than 3 months. 2) Previous CAR-T therapy of any target. 3) Have received any type of therapy targeting B7H3. 4) Uncontrolled hypertension (>160/95), unstable coronary artery disease with uncontrolled arrhythmia as evidence, instabilityPatients with fixed angina pectoris, decompensated congestive heart failure (> New York Heart Association Class II) or myocardial infarction within 6 months were studied. 5) Patients with severe liver and kidney dysfunction or consciousness disorder. 6) Patients with active hepatitis B. 7) HIV antibody and hepatitis C antibody positive patients. 8) Pregnant and/or lactating women. 9) Patients who are participating in or have participated in any other clinical trial within the last 30 days. 10) any problems that may be detrimental to the subject's ability to accept or tolerate planned treatment, understand informed consent at the study center, orAny situation in which, in the opinion of the Investigator, participation in the Study is not in the best interest of the Subject (e.g. to the detriment of health) or in any wayConditions that prevent, limit, or obfuscate the evaluation of research protocol requirements. 11) Subjects who have a family planning plan during the study period or within 100 days after the study treatment. 12) Other circumstances in which the investigator believes that he/she should not participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index;Pharmacokinetic evaluation index;Curative effect evaluation index; | — |
Countries
China
Contacts
Public ContactHu gang
Dermatology Hospital of Southern Medical University
Outcome results
None listed