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| Name | Class |
|---|---|
| South China Hospital of Shenzhen University | UNKNOWN |
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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).
Main purpose:
Evaluate the safety and tolerability of BST08 treatment in subjects with advanced non-small cell lung cancer.
Secondary purpose:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BST08 | Experimental | Intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single drug group A | Biological | 9x10^10 BST08 cells, Intravenous infusion,3 subject is planned to be enrolled |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From the infusion (Day 0) to Day 28 |
| 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) | From the infusion (Day 0) to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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);
5: Organ transplantation, hematopoietic stem cell transplantation history;
6. Other serious medical conditions that may limit participants' participation in this trial
7: HIV positive, or treponema pallidum antibody positive;
8: Active hepatitis B infection, defined as Hepatitis B core antibody (HBcAb) or Hepatitis B surface antigen (HBsAg) positive with HBV-DNA> 10,000 IU/ml, or 200 IU. Or hepatitis C, defined as HCV RNA above the lower limit for clinical trial center detection. These patients will need to continue taking antiviral drugs during the study period;
9: Any immunosuppressive drugs, such as corticosteroids, were used in the 4 weeks prior to the tumor tissue sampling, or co-existing diseases were determined by the investigator to require the use of immunosuppressive drugs during the trial. However, the use of physiological doses of corticosteroids (i.e., no more than 15mg/ day of prednisone or equivalent doses of other corticosteroids) is permitted, and the use of corticosteroids for inhalation, intranasal, topical or prophylactic use of contrast media allergies is permitted;
10: Local treatment such as interventional therapy, radiotherapy, ablation and systemic treatment (including small molecule targeted drugs, anti-PD-1 / PD-L1 monoclonal antibodies and chemotherapy, etc.) had been received within 4 weeks before pretreatment. Or received thymosin, interferon and other immunotherapy or any Chinese herbal medicine or proprietary Chinese medicine for tumor control within 1 week prior to pretreatment;
11: Those who have received live vaccine within 3 months prior to screening or plan to receive live vaccine during the trial;
12: Patients who underwent major surgery (≥ Grade 3 surgery) within 4 weeks prior to screening, or who required elective surgery during the trial period (other than tumor tissue sampling surgery/puncture);
13: Patients who had surgical complications or delayed wound healing prior to pretreatment, and who were judged by the investigators to increase the risk of eluviation, TIL treatment, or infection;
14: diagnosed with other primary malignancies within 5 years prior to screening, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ;
15: Genetically modified cell therapy products received 6 months before pretreatment;
16: Participants with known alcohol, drug, or substance abuse and other conditions deemed inappropriate by the researchers to participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqing Li, PhD | Contact | 15018487211 | liyu2t@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuqing Li, PhD | South China Hospital of Shenzhen University | Principal Investigator |
| Mingyong Han, PhD | South China Hospital of Shenzhen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuqing Li | Shenzhen | Guangdong | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Combined treatment group B | Biological | 9x10^10 BST08 cells+ Pembrolizumab Injection,200mg,Q3W, Intravenous infusion,6subject is planned to be enrolled |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |