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);
Single group
Single drug group A
Biological/Vaccine9x10\^10 BST08 cells, Intravenous infusion，3 subject is planned to be enrolled
Combined treatment group B
Biological/Vaccine9x10\^10 BST08 cells+ Pembrolizumab Injection，200mg，Q3W, Intravenous infusion，6subject is planned to be enrolled
Dose-Limiting Toxicity (DLT)
DLT is defined as the following adverse events related to the investigational drug (definitely related, likely related, possibly related) that occur within 28 days after administration of BST08 (using CTCAE 5.0 or CRS grading criteria): (1) hematological toxicity; (2) Grade 3 non hematological toxicity lasting for more than 7 days, or ≥ Grade 4 non hematological toxicity, regardless of duration, but excluding the following situations; (3)Cytokine Release Syndrome(CRS)
Maximum ToleratedDose（MTD）
The highest dose of DLT observed in subjects with less than 2/6 (at least 6 subjects in this experimental group received BST08 administration and completed DLT observation)
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BioSyngen Pte Ltd
Lead sponsor
South China Hospital of Shenzhen University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
