Non-small Cell Lung CancerNCT06643910
A Study on the Safety and Efficacy of BST08 in Treating Advanced Non-Small Cell Lung Cancer
A study testing Single drug group A and Combined treatment group B in people with Non-small Cell Lung Cancer, run by BioSyngen Pte Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Single drug group A and Combined treatment group B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 5: Eastern Cooperative Oncology Group (ECOG) score ≤1 score;
- 6: Expected survival time ≥3 months;
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- 7: Adequate organ and bone marrow function during the screening and preparation phase (within 14 days prior to tumor tissue sampling)
- 8: Prior to the tumor tissue sampling, the adverse reactions caused by previous treatment had returned to the Common Adverse Event Evaluation Criteria (CTCAE) 5.0≤2 (except for alopecia, peripheral neurotoxicity of grade 2 or below, and other toxicities that researchers judged to have no safety risk);
- 9: From the signing of the informed consent to the acceptance of effective contraceptive measures within 6 months after the BST08 infusion (subjects must use non-drug contraceptive measures);
- 10: Those who fully understand the test and voluntarily sign the informed consent, and can comply with the visit and related procedures stipulated in the program
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Yuqing Li
Shenzhen, Guangdong
Yuqing Li, PhD, 15018487211, liyu2t@163.com
About this study
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).
Read the detailed description
Main purpose:
Evaluate the safety and tolerability of BST08 treatment in subjects with advanced non-small cell lung cancer.
Secondary purpose:
- Evaluate the preliminary effectiveness of BST08 in the treatment of advanced non-small cell lung cancer subjects;
- Evaluate the pharmacokinetic (PK) characteristics of BST08.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Single drug group A, Combined treatment group B
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single drug group ABiological
9x10^10 BST08 cells, Intravenous infusion，3 subject is planned to be enrolled
Combined treatment group BBiological
9x10^10 BST08 cells+ Pembrolizumab Injection，200mg，Q3W, Intravenous infusion，6subject is planned to be enrolled
| Study group | Role | What they receive |
|---|---|---|
| BST08 | Experimental | Intravenous infusion Receives: Biological: Single drug group A; Biological: Combined treatment group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: From the infusion (Day 0) to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start24 Oct 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSyngen Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- South China Hospital of Shenzhen University
- Responsible party
- Sponsor
- Investigators
- Yuqing Li, PhD, Principal investigator, South China Hospital of Shenzhen UniversityMingyong Han, PhD, Principal investigator, South China Hospital of Shenzhen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643910
- Sponsor's protocol ID
- BR-BST08-001
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Efficacy of BST08 in Treating Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06643910
- Acronym / sponsor ID
- BR-BST08-001
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- BioSyngen Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- South China Hospital of Shenzhen University
- Study start
- 24 Oct 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Main purpose:
Evaluate the safety and tolerability of BST08 treatment in subjects with advanced non-small cell lung cancer.
Secondary purpose:
- Evaluate the preliminary effectiveness of BST08 in the treatment of advanced non-small cell lung cancer subjects;
- Evaluate the pharmacokinetic (PK) characteristics of BST08.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BST08 | Experimental | Biological: Single drug group A, Biological: Combined treatment group BIntravenous infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- 5: Eastern Cooperative Oncology Group (ECOG) score ≤1 score;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single drug group A9x10^10 BST08 cells, Intravenous infusion，3 subject is planned to be enrolled | Biological | BST08 |
| Combined treatment group B9x10^10 BST08 cells+ Pembrolizumab Injection，200mg，Q3W, Intravenous infusion，6subject is planned to be enrolled | Biological | BST08 |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: From the infusion (Day 0) to Day 28
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）
Time frame: From the infusion (Day 0) to Day 28
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuqing Li, PhD principal investigator
South China Hospital of Shenzhen University
Mingyong Han, PhD principal investigator
South China Hospital of Shenzhen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single drug group A and Combined treatment group B in people with Non-small Cell Lung Cancer, run by BioSyngen Pte Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqing Li, PhD (15018487211, liyu2t@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: From the infusion (Day 0) to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.