A Study on the Safety and Efficacy of BST08 in Treating Advanced Non-Small Cell Lung Cancer

NCT06643910 | Not Yet Recruiting

• 1 other identifier: BR-BST08-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

BST08

EXPERIMENTAL

Intravenous infusion

Biological: Single drug group A; Biological: Combined treatment group B

Interventions

Single drug group A BIOLOGICAL

9x10\^10 BST08 cells, Intravenous infusion，3 subject is planned to be enrolled

BST08

Combined treatment group B BIOLOGICAL

9x10\^10 BST08 cells+ Pembrolizumab Injection，200mg，Q3W, Intravenous infusion，6subject is planned to be enrolled

BST08

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Age 18-70 years old (including the critical value);
• : 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.
• : 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.
• : At least one measurable lesion as defined by the RECIST 1.1 standard;
• : Eastern Cooperative Oncology Group (ECOG) score ≤1 score;
• : Expected survival time ≥3 months;
• : Adequate organ and bone marrow function during the screening and preparation phase (within 14 days prior to tumor tissue sampling)
• : 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);
• : 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);
• : 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

You may not qualify if:

• : Pregnant or lactating women;
• \. Subjects with a history of severe allergy to the experimental drug, including but not limited to cyclophosphamide, fludarabine, and BST08 components;
• : 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;
• : Extensive liver metastasis was confirmed (imaging estimated tumor volume accounted for ≥50% of the total liver volume);
• : Organ transplantation, hematopoietic stem cell transplantation history;
• \. Other serious medical conditions that may limit participants' participation in this trial
• : HIV positive, or treponema pallidum antibody positive;
• : 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;
• : 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;
• : 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;
• : Those who have received live vaccine within 3 months prior to screening or plan to receive live vaccine during the trial;
• : 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);
• : 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;
• : 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;
• : Genetically modified cell therapy products received 6 months before pretreatment;

Sponsors & Collaborators

• BioSyngen Pte Ltd: lead
• South China Hospital of Shenzhen University: collaborator

Study Sites (1)

Yuqing Li

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuqing Li, PhD

  South China Hospital of Shenzhen University

  PRINCIPAL INVESTIGATOR

• Mingyong Han, PhD

  South China Hospital of Shenzhen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqing Li, PhD

CONTACT

15018487211; liyu2t@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

CN (1)