This study is an exploratory clinical trial initiated by an open, single arm researcher to evaluate the safety, tolerability, and preliminary efficacy of BST08 in the treatment of advanced non-small cell lung cancer in subjects. This study plans to set up two experimental groups: monotherapy group A: 9x10 \^ 10 BST08 (3 cases) and combination therapy group B: 9x10 \^ 10 BST08+Pabolizhu 200mg Q3W (6 cases).
1: Age 18-70 years old (including the critical value);
2: Non-small cell lung cancer diagnosed by histopathology or cytology without driver mutation progresses after receiving at least second-line systemic therapy including anti-PD-1 /L1 monoclonal antibody.
3: At least one tumor lesion has not received radiation therapy or other local treatment within 28 days. In addition, according to the researchers' judgment, at least 2 tumor puncture samples (from different lesions) with good integrity and ≥2cm length can be obtained by surgical resection or puncture for the preparation of BST08.
4: At least one measurable lesion as defined by the RECIST 1.1 standard;
1: Pregnant or lactating women;
2. Subjects with a history of severe allergy to the experimental drug, including but not limited to cyclophosphamide, fludarabine, and BST08 components;
3: Past or current presence of hepatic encephalopathy; Other patients with known uncontrolled or untreated central nervous system metastases; Patients with stable symptoms who had received treatment and stopped treatment with corticosteroids and anticonvulsants ≥4 weeks prior to preconditioning were excluded;
4: Extensive liver metastasis was confirmed (imaging estimated tumor volume accounted for ≥50% of the total liver volume);
BioSyngen Pte Ltd
Lead sponsor
South China Hospital of Shenzhen University
Collaborator