NCT07096882招募中1 期
Phase I Clinical Trial of SDTM001 Injection as Adjuvant Treatment for NSCLC Patients With Driver-gene-negative and Negative PD-L1 Expression After Radical Surgical Resection
Cytocraft Biopharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年7月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Safety profile of SDT-M001 injection
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety profile and tolerability of SDT-M001 injection in NSCLC patients with driver-gene-negative and negative PD-L1 expression after radical surgical resection; to determine the recommended Phase II dose (RP2D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants must be informed of the trial before any examinations stipulated in this trial are initiated, voluntarily sign the written informed consent form (ICF) approved by the ethics committee, and be able to comply with the research procedures.
- •Age ranges from 18 to 70 years old (including threshold), regardless of gender.
- •For participants diagnosed with primary NSCLC according to the standards of the "Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer(2024 edition)" and the "Clinical Practice Guideline for Primary Lung Cancer(2022 Version)", and who have undergone radical surgical resection (R0) treatment, the TNM stage is classified as stage IIA - IIIB according to the American Joint Committee on Cancer staging system(AJCC),9th edition.
- •There is no disease recurrence (including local recurrence) after radical surgical resection (R0) treatment, and the estimated time of apheresis is within one year after the operation.
- •Previous tests for driver gene mutations (e.g., EGFR, ALK) were negative, and PD-L1 expression in tumor tissues was negative as detected.
- •Platinum-based chemotherapy (one to four cycles) has been completed before screening.
- •The ECOG performance status score is ≤1 point, the expected survival time is ≥12 months, and follow-up can be conducted as stipulated in the protocol.
- •Major organ functions must be normal (no corrective treatment with any blood components, cell growth factors, or albumin infusion within 14 days before obtaining laboratory tests) and meet the following requirements: White blood cells (WBC) ≥3.5×109 cells/L, lymphocytes (LYM) ≥0.8×109 cells/L, platelets (PLT) ≥80×109 cells/L, absolute neutrophil count ≥1.5×109 cells/L, hemoglobin ≥90g/L; Total bilirubin ≤1.5×upper limit of normal value (ULN), alanine aminotransferase (ALT) ≤2.5×ULN, aspartate aminotransferase (AST) ≤2.5×ULN; Creatinine ≤1.0×ULN, or creatinine clearance rate ≥60mL/min (using the Cockcroft-Gault method); International Normalized Ratio (INR) ≤1.
- •Participants must have sufficient venous access for the apheresis.
- •Eligible participants with fertility (both male and female) must agree to use reliable contraceptive methods (hormones or barrier methods or abstinence) during the trial and for at least one year after the last reinfusion of SDTM001 injection; Female participants within childbearing age must have a negative pregnancy blood test within 7 days prior to enrollment; Male participants were not allowed to donate sperm from the first infusion to one year after the last infusion.
排除标准
- •Participants who have participated in other clinical trials of investigational agents or devices for therapeutic intent within 4 weeks prior to screening.
- •Participants who have received cancer treatment such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to screening.
- •Participants who underwent gene-modified anti-tumor immune cell therapy (e.g., CAR-T cells, CAR-NK cells) within one year or non-gene-modified therapy (e.g., NK cells, DC cells, DC-CIK cells) within half a year prior to screening.
- •Participants with impaired cardiac function or significant cardiovascular diseases, including any of the following:
- •(1) Acute myocardial infarction or unstable angina pectoris ≤6 months prior to screening; (2) New York Heart Association classified III/IV congestive cardiac failure; (3) Uncorrected severe arrhythmia and hypertension ≥150/100 mmHg; (4) Prolonged QTc interval (> 450ms in males , > 470ms in females); (5) History of other significant cardiovascular diseases (e.g., valve replacement surgery, coronary artery bypass grafting).
- •Participants with a history of drug addiction, alcoholism (defined as average daily pure alcohol intake ≥61g for men or ≥41g for women), or substance abuse.
- •Participants with systemic active infections requiring treatment, including but not limited to HIV-positive, syphilis positive, or clinically active hepatitis A/B/C infection.
- •Participants with severe autoimmune diseases or immunodeficiency, such as those requiring long-term (≥2 months) systemic immunosuppressant (e.g., steroid) for severe autoimmune diseases, or those with severe immune-mediated symptomatic diseases (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis(e.g., Wegener granulomatosis)).
- •Participants who require systemic immunosuppressants (e.g., cortisol, hydroxyurea) within 28 days prior to screening or during the trial, or other immunomodulators (e.g., interferon-alpha/gamma, GM-CSF, mTOR inhibitors, cyclosporine, thymosin).
- •Participants with a history of organ transplantation, allogeneic stem cell transplantation or renal replacement therapy;
- •Participants who have received live vaccines within 28 days prior to screening or plan to receive live vaccines during the study period.
- •Participants who have undergone major operations within 4 weeks prior to screening.
- •Participants with known allergic reactions to SDT-M001 injection, its active ingredients, excipients, or a history of allergy to cell products
- •Participants with a history of or current other malignant tumors, except:
- •Malignant tumors with no recurrence for ≥5 years after radical treatment
- •Cured cervical cancer or breast carcinoma in situ, basal cell carcinoma or squamous cell carcinoma.
- •Participants with any mental illness or severe mental disorder (e.g., dementia, altered mental status) that may affect informed consent or comprehension of questionnaires.
- •Breastfeeding women are excluded.
- •Participants who are deemed by the investigator to be unable to complete trial visits, evaluations, or follow-ups, have poor compliance, or are otherwise unsuitable for inclusion.
研究组 & 干预措施
SDT-M001 injection
Experimental
干预措施: SDT-M001 injection (Biological)
结局指标
主要结局
Safety profile of SDT-M001 injection
时间窗: From enrollment up to 24 Months After the end of the last infusion
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards. Adverse events (AE) of all subjects entering this trial, including serious adverse events (SAE); laboratory examination indicators.
Tolerability of SDT-M001 injection
时间窗: From enrollment to 28 days after the end of the last infusion
The number and severity of dose-limiting toxicity (DLT) events. Calculate the incidence of DLT.
RP2D
时间窗: Until the end of the study
If the maximum tolerated dose (MTD) has been proven to be feasible for long-term clinical administration in a reasonable number of subjects, then this dose is usually RP2D.
次要结局
- Therapeutic effect evaluation(From enrollment up to 24 Months After the end of the last infusion.)
研究者
研究点 (1)
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