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Feasibility and safety of CAR-T cells in patients with central nervous system malignant tumor

Chimeric Antigen Receptor T-Cell Immunotherapy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023435
Enrollment
Unknown
Registered
2019-05-27
Start date
2018-08-01
Completion date
Unknown
Last updated
2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

central nerve system tumor

Interventions

CAR-T:CAR-T cell infusion

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. IL-13Ra2, B7H3, EGFRvIII or CD19-positive glioblastoma or lymphoma in brain is verified by immunohistochemical analysis or PCR; 2. Diseace progression is observed after standard surgeryradiotherapy and chemotherapy treatment, with no other effective therapy available; 3. The patient is not under glucocorticoid therapy, or has stop using glucocorticoid for over 5 days; 4. According to RECIST1.1 criteria, measurable focus is observed in imaging examination; 5. Patient gets a Karnofsky appraisal > 60 scores; 6. Regardless of gender, the patient should be over 18 years old; 7. Estimated lifetime should be over 3 months; 8. Important viscera function: (1) Ejection fraction is over 50% according to cardiac ultrasound; (2) No significant change is found in electrocardiogram; (3) Oxygen saturation is higher than 90%; 9. Hematological test and biochemical detection: (1) Neutrophil count > 1000/ml with no colony stimulation factors used; (2) White blood cell count > 2000/ml; (3) Blood platelet count > 100,000/ml; (4) Hemoglobin > 8.0g. When patients are under this criteria, transfusion may be under consideration; (5) ALT/AST < 2.5 folds of the normal maximum index; (6) Total bilirubin < 1.5 folds of the normal maximum index; (7) Creatinine < 1.6mg/ml; 10. All of the participant should have the willing and ability to sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) The patient gets a history of immunological disease, or is under the use of glucocorticoid drugs or other immunosuppressive therapy due to other disease. (2) The patient is confronted with irrelievable hypoxia, hypertension, heart failure, serious arrhythmia, asthma, respiratory failure or nephropathy requiring dialysis. (3) The patient is under progressive infection, HIV infection or progressive hepatitis B or C. (4) The patient is under seizures out of control, or progressive brain disease with significant clinical features. (5) The patient gets other progressive tumors. (6) The patient is under pregnancy or lactation. (7) The patient refuses to take contraception during treatment and the next year following. (8) The patient has already joined another clinical trial. (9) The patient is a male with reproduction intention. (10) There exist other factors assessed by researchers that affect patients participation.

Design outcomes

Primary

MeasureTime frame
MRI;PET-CT;cytokine;liver fuction;kidney fuction;blood pressure;body temperature;intracranial pressure;

Countries

China

Contacts

Public ContactLiangxue Zhou

Neurosurgery Department, West China Hospital, Sichuan University

liangxue_zhou@126.com+86 18980602265

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026