A Single-arm, Open, Exploratory Clinical Study of Allogeneic CAR-T Cells in the Treatment of Relapsed/Refractory Brain Gliomas With Positive CD70 Expression

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

The goal of this clinical trial is to learn if allogeneic CAR-T cells can treat patients with advanced gliomas. The main questions it aims to answer are: Evaluate the safety of allogeneic CAR-T cells in the treatment of advanced gliomas. To evaluate the effectiveness of allogeneic CAR-T cells in the treatment of advanced gliomas and to study its immunological properties in patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 1\) Agree to follow the study treatment plan and visit plan, voluntarily enroll, and sign the informed consent in writing; 2) Aged ≥18 years old on the day of signing the informed consent, regardless of gender; 3) Patients with recurrent/refractory glioma who have failed or cannot tolerate standard treatment and whose CD70 expression is confirmed by cytology or histology; 4) According to the results of immunohistochemistry test in a tertiary hospital (if historical tissue samples show CD70 positivity, no retest is required; if historical tissue samples show CD70 negative, a puncture biopsy is required) \[historical archived tissue samples within 2 years are acceptable\], the CD70 expression in the tumor site of the subject meets the positive standard, that is, ≥2+; 5) According to the RANO standard (Appendix 1), there is at least one evaluable or measurable lesion; 6) The expected survival period is ≥12 weeks; 7) The baseline Kanofsky performance score (Kanofsky performance score, KPS) score ≥ 70 points; 8) Subjects have adequate organ and bone marrow function and meet the following laboratory test standards: Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×109/L (1500/mm3); platelets (PLT) ≥ 90×109/L (1×105/mm3) (no blood transfusion or use of auxiliary white blood cells and platelets within 14 days before screening); White blood cell count ≥ 3.0×109/L (3000/mm3); Hemoglobin (HGB) ≥ 9.0 g/dL; Liver function: serum bilirubin (T-Bil) ≤ 1.5 times the upper limit of normal (ULN), Gilbert's syndrome (Gilbert's syndrome) (persistent or recurrent hyperbilirubinemia, manifested as elevated unconjugated bilirubin in the absence of evidence of hemolysis or liver pathology); patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN, patients with liver metastasis, ALT and AST ≤ 5 times ULN; Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance (Ccr) ≥ 50 mL/min (Ccr is calculated using the Cockcroft-Gault formula, see Appendix 5); Coagulation function: international normalized ratio (INR) ≤ 1.5 times ULN, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; 9) The investigator judges that the patient must have fully recovered from the previous treatment toxicity to ≤ Grade 1, except for the following situations: a. Alopecia; b. Pigmentation; c. Late toxicity caused by radiotherapy, which cannot be recovered by the investigator; d. Neurotoxicity of Grade 2 or below caused by platinum (CTCAE 5.0); Fertility-bearing male and female subjects of childbearing age must use effective contraceptive methods from the time they sign the informed consent until at least 6 months after CAR-T administration, and until 2 consecutive PCR tests show that there are no more CAR-T cells in the body. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test result within 7 days before the first dose.

Locations
Other Locations
China
Nanjing Jinling Hospital
RECRUITING
China
Contact Information
Primary
Jiang Longwei, master
jianglw2005@163.com
+86-13952007724
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 3
Treatments
Experimental: allogeneic CAR-T targeting CD70
The enrolled patients will be received allogeneic CAR-T targeting CD70 that culutred from heathy adults. 1E6/kg CAR-T cells will be injected once from intrathecal.
Related Therapeutic Areas
Sponsors
Leads: JIANG LONGWEI
Collaborators: Nanjing Kanghe Cell Gene Engineering Research Institute Co., Ltd.

This content was sourced from clinicaltrials.gov