NCT07652125招募中不适用
An Exploratory Study of RGL-270 in Combination With PD-1/PD-L1 Inhibitors in Patients With Unresectable Locally Advanced or Recurrent/Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety Endpoints
研究概览
简要总结
This is a single-center, open-label, investigator-initiated clinical trial. It aims to evaluate the safety and tolerability of RGL-270 in combination with a PD-1/PD-L1 inhibitor, to assess immunogenicity, preliminary efficacy, and exploratory biomarkers and to observe the safety and effectiveness of PD-1/PD-L1 inhibitor monotherapy in advanced NSCLC subjects through a real-world observational cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects capable of understanding/compliance with study procedures and voluntarily signing informed consent.
- •Age ≥18, any gender.
- •Histologically/cytologically confirmed NSCLC.
- •5.ECOG performance status 0 or
- •6.Life expectancy ≥6 months.
- •7. Subject must have at least one measurable tumor lesion by RECIST 1.1 criteria at baseline prior to first-line treatment.
- •Note: Previously irradiated lesions not eligible as target lesions unless documented progression post-radiation.
- •8. Subjects with asymptomatic central nervous system (CNS) metastases (excluding meningeal or cerebrospinal membrane metastases) are allowed. For symptomatic CNS metastases, the condition must be stable after local treatment and no steroid or anticonvulsant treatment is required at least 7 days before enrollment (antiepileptic drugs are allowed).
- •9.Willing to provide sufficient fresh tumor tissue or archival specimens for genomic profiling and neoantigen analysis (fresh tissue preferred).
- •10.Willing to provide blood samples for immunogenicity/biomarker assessments at all timepoints. Pre-biopsy samples require no transfusion/blood products/G-CSF within 10 days.
- •11.Adequate organ function (no blood products/growth factors within 10 days prior to testing):
- •Hematology:
- •ANC ≥1.5×10⁹/L, LYM ≥0.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90g/L
- •Biochemistry:
- •TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, ALB ≥30g/L, Scr ≤1.5×ULN
- •Coagulation:
- •INR ≤1.5, APTT ≤1.5×ULN
- •QTcF <470 ms (Fridericia's correction: QTcF=QT/RR⁰·³³)
- •12.Women of childbearing potential (WOCBP): Negative pregnancy test within 7 days prior to treatment; non-lactating.
- •13.Women and male subjects with fertile partners must use contraception from consent until 90 days post-last treatment (see Appendix V).
- •Real-World Observational Cohort Addendum:
- •Exempt from tissue provision (Criterion 9) and immunogenicity blood sampling (Criterion 10). All other inclusion criteria apply.
排除标准
- •Histologically/cytologically confirmed small cell lung cancer (SCLC), mixed tumors with SCLC components, neuroendocrine tumors with large cell components, or sarcomatoid carcinoma.
- •Actionable driver mutations (e.g., EGFR/ALK) where targeted therapy is accessible per investigator assessment, except for patients refusing targeted treatment.
- •Prior radiotherapy within 5 years or history of immunotherapy/cancer vaccines (including but not limited to TILs, CAR-T, TCR-T, therapeutic cancer vaccines).
- •Live vaccines administered ≤28 days pre-screening or planned during study/within 90 days post-treatment (inactivated vaccines permitted).
- •Investigator-assessed contraindications for immunotherapy.
- •Active autoimmune diseases (exclusion: hypothyroidism from autoimmune thyroiditis requiring hormone replacement only).
- •Evidence of active tuberculosis within 1 year pre-screening, regardless of treatment.
- •History of interstitial lung disease (ILD), suspected active ILD on screening CT, or idiopathic pulmonary fibrosis/organizing pneumonia (e.g., BOOP/cryptogenic OP).
- •Severe active infection requiring IV antibiotics/antifungals/antivirals ≤28 days pre-screening or during screening.
- •Clinically uncontrolled effusions requiring drainage ≤14 days pre-screening (pleural/peritoneal/pericardial).
- •Hypersensitivity to study drug excipients or severe vaccine allergy history.
- •Other malignancies within 5 years (exceptions: cured cervical CIS, basal/squamous skin cancer, localized prostate cancer post-radical therapy, DCIS, papillary thyroid cancer).
- •Allogeneic organ or hematopoietic stem cell transplantation.
- •Congenital/acquired immunodeficiency (e.g., DiGeorge syndrome, T-/B-cell deficiencies, Wiskott-Aldrich, ataxia-telangiectasia, CVID) or HIV infection.
- •Active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] at screening AND HBV DNA ≥500 IU/mL or above the upper limit of normal [ULN] at the local institution), OR active hepatitis C (defined as positive hepatitis C antibody [HCV-Ab] at screening AND detectable HCV-RNA).
- •Uncontrolled or significant cardiovascular disease, including:
- •Symptomatic congestive heart failure (NYHA Class III or IV) Myocardial infarction within 6 months prior to screening Unstable angina within 1 month prior to screening Clinically significant arrhythmias requiring therapeutic intervention Refractory hypertension despite adequate treatment (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg)
- •Any other condition deemed by the investigator to potentially compromise trial conduct or outcome interpretation, including but not limited to:
- •Anticipated poor compliance with study procedures Comorbidities posing unacceptable safety risks Insufficient neoantigen burden for vaccine production (based on tumor sequencing analysis) Vaccine manufacturing failure
- •Subjects who experienced severe irAE during the run-in treatment period resulting in permanent discontinuation of PD-1/PD-L1 inhibitors.
- •If a subject experiences comprehensive disease progression during the introduction treatment but only has clinical deterioration, or if the intracranial lesion stabilizes after local treatment and the investigator assesses that medication can continue, they are allowed to continue participating in the study.
研究组 & 干预措施
the real-world observational cohort
Other
Physician's Choice SOC as the parallel control
干预措施: Physician's Choice SOC (Other)
the study cohort
Experimental
The purpose of the study arm is to evaluate the safety, tolerability, immunogenicity, and preliminary effectiveness of the RGL-270 in combination with a PD-1/PD-L1 inhibitor in subjects with advanced non-small cell lung cancer (NSCLC)
干预措施: RGL-270 in Combination with PD-1/PD-L1 Inhibitors (Biological)
结局指标
主要结局
Safety Endpoints
时间窗: through study completion, an average of 3 years.
To evaluate the safety and tolerability of personalized tumor vaccine in combination with PD-1/PD-L1 inhibitors in patients with advanced NSCLC.
次要结局
- Evaluate the immunogenicity of personalized tumor vaccine(through study completion, an average of 3 years.)
- To evaluate the preliminary efficacy of personalized tumor vaccine combined with PD-1/PD-L1 inhibitors in patients with advanced NSCLC(through study completion, an average of 3 years.)
研究者
Zhou Qing
Principal Investigator
Guangdong Association of Clinical Trials
研究点 (1)
Loading locations...
相似试验
招募中
Unknown
A study in participants who requires facial improvement through dermal fillerCTRI/2025/01/078955Biotech vision care pvt ltd85
招募中
1 期
Safety and Efficacy of GL-2045 in Patients With Immune ThrombocytopeniaImmune ThrombocytopeniaNCT07605845Gliknik Inc.42
招募中
2 期
A study to test the benefits and safety of GL0034 in people with type 2 diabetes who are overweight or obese and have health problems related to their weightCTRI/2025/12/098880Sun Pharmaceutical Industries Limited (SPIL)285
尚未招募
1 期
The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.NCT07445308Shenyang Sunshine Pharmaceutical Co., LTD.120
尚未招募
2/3 期
A study of two Ayurvedic heat treatments to improve pain and shoulder movement in Frozen shoulder.CTRI/2026/01/102465Dr Dayasagar Balajirao Jadhav60