Recurrent glioblasts
Conditions
Interventions
multiple ascending doses:XYF13 Car-T
Sponsors
The First Affiliated Hospital of the Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)18= age =70 years old, gender is not limited; (2) Histologically or cytologically confirmed patients with recurrent glioblastoma after treatment with STUPP regimen (TMZ concurrent chemoradiotherapy and adjuvant chemotherapy regimen); (3) According to RANO criteria, have evaluable or measurable (measurable enhancement lesions are defined as enhancement lesions with well-defined upper boundaries on CT or MRI, capable of developing on =2 axial radiographs with a thickness of 5 mm and perpendicular to each other with an average length diameter > 10 mm. If the thickness of the scan layer is large, the minimum lesion should be measured. 2 times thick) tumor lesions; (4) The lesion should be resectable when subjects are enrolled, and the degree of resection can reach 80-100%. (5) Clinical pathology (immunohistochemical staining) confirmed the positive expression of IL13Ra2 > 30%; (6) Sufficient peripheral blood can be obtained through veins, and there are no other contraindications for lymphocyte collection; Peripheral blood cells can be collected according to the requirements of cell preparation. (7)KPS score =60 points; (8) Expected survival time =3 months; (9) The subject must give informed consent to the experiment before the experiment, and a written informed consent must be voluntarily signed by the subject (or his legal representative).
Exclusion criteria
Exclusion criteria: (1) within 6 months after the last radiotherapy; (2) Subjects with neoplastic lesions in the brain stem; (3) Received immunosuppressant or glucocorticoid therapy within 2 weeks before enrollment; (4) those who received live vaccine within 4 weeks prior to enrollment and/or plan to receive live vaccine after enrollment; (5) Received chemical therapy within 2 weeks prior to enrollment or 5 half-lives (whichever is shorter); (6) Did not recover from adverse events caused by previous antitumor therapy before enrollment (to = grade 1 according to CTCAE v5.0), except hair loss and sequelae; (7) Previously received an organ transplant; (8) Patients who could not undergo brain MRI examination; (9) Any of the following abnormalities appear in the laboratory examination: a) Blood routine: absolute neutrophil count (ANC) 1.5×ULN (upper limit of normal); c) Liver function: total bilirubin (TBIL) > 2×ULN (upper limit of normal), or alanine transferase (ALT), aspartate transferase (AST) > 3×ULN; d) Renal function: serum creatinine (Cr) =1.5×ULN, or glomerular filtration rate (GFR) < 60ml/min·1.73m2; e) Treated subjects with active hepatitis B (HBsAg positive with more than 1000 copies /ml (200 IU/ml) of HBV-DNA or higher than the lower limit of detection, whichever is higher); For subjects with hepatitis B, anti-hepatitis B therapy is required during study treatment; Subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection), human immunodeficiency virus or acquired immunodeficiency syndrome (HIV) related disease. f) Cardiac ultrasound: left ventricular ejection fraction (LVEF) < 50%; (10) Acute bacterial or fungal infections requiring intravenous antibiotics during cell retransfusion; (11) Negligent compensatory heart failure (NYHA grades III and IV), unstable angina pectoris, acute myocardial infarction, and persistent and clinically significant arrhythmias within 3 months prior to enrollment; (12) Patients who required oxygen inhalation to maintain blood oxygen saturation above 95% before enrollment and could not return to normal within 2 weeks; (13) Have a history of tuberculosis; (14) suffering from other malignant tumors that have not been effectively controlled; (15) People who are known or expected to have an allergic reaction to, or have a history of, any of the ingredients treated in this trial; (16) known allergy to contrast media; (17) Have a clear history of mental disorders; (18) Have a history of drug abuse or drug use; (19) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period; (20) Women of reproductive age and fertile men who were unable to use effective and adequate contraceptive methods (such as intrauterine devices, condoms, spermicide gel plus condoms, diaphragms, etc.) during the period of receiving the study drug and 3 months after the end of the study; (21) Participants who participated in other clinical trials within 30 days prior to study enrollment; (22) Participants judged by the investigator to be unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival(PFS);Overall survival (OS);Time to disease progression (TTP);Objective response rate (ORR);Duration of response (DOR);Karnofsky(KPS);Quality of Life score (QLQ-C30, QLQ-BN20); | — |
Countries
China
Contacts
Public ContactSanzhong Li
The First Affiliated Hospital of the Air Force Military Medical University. Xijing Hospital
Outcome results
None listed