Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001 in the Treatment of Patients With Recurrent/Progressive Non-small Cell Lung Cancer

Henan Cancer Hospital1 个研究点分布在 1 个国家目标入组 42 人2025年6月25日

干预措施BioTTT001 injection

概览

阶段: 1 期
干预措施: BioTTT001 injection
疾病 / 适应症: 未指定
发起方: Henan Cancer Hospital
入组人数: 42
试验地点: 1
主要终点: DLT, MTD and/or RP2D
状态: 招募中
最后更新: 4个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Phase Ib/II clinical study on evaluating the safety, tolerance, biodistribution characteristics and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTT001) in the treatment of meningeal metastasis in recurrent/progressive non-small cell lung cancer

详细描述

This study is a single-arm, open-label, dose-escalation and dose-expansion phase Ib/II clinical trial aimed at evaluating the safety, tolerability, biological distribution characteristics, and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in patients with recurrent/progressive non-small cell lung cancer with meningeal metastases. The study is divided into two phases: the phase Ib dose-escalation .The dose escalation phase establishes three dosage groups, namely 1.0×10\^9 VP, 5.0×10\^9 VP, and 1.0×10\^10 VP and the phase II dose-expansion.

注册库

clinicaltrials.gov

开始日期

2025年6月25日

结束日期

2027年12月30日

最后更新

4个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Henan Cancer Hospital

责任方

Sponsor

入排标准

入选标准

•Age between 18 and 70 years old (including boundary values);
•Patients diagnosed with NSCLC through pathological histology, who have experienced recurrence or progression after standard treatment, and have tumor cells found in cerebrospinal fluid or MRI diagnosis of leptomeningeal metastasis;
•Performance Status (PS) score ≤ 3 points;
•Suitable for Ommaya reservoir placement as determined by the investigator, and meet the conditions for drug administration;
•Expected survival ≥ 3 months;
•Good organ function, defined as follows:
•Blood routine (not having received blood transfusion or other treatments within 14 days): Absolute neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.0 × 10\^9/L;
•Coagulation function: Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN), International Normalized Ratio (INR) ≤ 1.5 times ULN;
•Liver function: Total bilirubin (TBIL) ≤ 1.5 times ULN, Gilbert's syndrome participants should be ≤ 3 times ULN, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times ULN (if there is liver metastasis, ALT or AST ≤ 5 times ULN);
•Renal function: Serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault formula calculation see Appendix 3);

排除标准

•Patients who have received systemic antitumor therapy within two weeks, including intravenous chemotherapy, intrathecal chemotherapy, or whole-brain radiotherapy (excluding immunotherapy);
•immunotherapy administered within 6 weeks prior to the first dose;
•traditional Chinese medicine with antitumor indications administered within 2 weeks prior to the first dose;
•patients with uncontrolled epilepsy;
•those who received any other investigational drug within 4 weeks prior to the first dose;
•major organ surgeries (excluding biopsy) or significant trauma within 4 weeks prior to the first dose, or those requiring elective surgery during the study;
•patients with prior history of cell therapy, gene therapy, or oncolytic virus therapy;
•individuals with known or suspected allergies to active ingredients, excipients, or contrast agents in the study drug or imaging contrast agents;
•patients with organ transplant history or planned organ transplant during the study;
•active infections requiring systemic intravenous treatment or uncontrolled infections, or unexplained fever\>38.5℃ occurring during screening or before the first dose;

研究组 & 干预措施

Recombinant human nsIL12 oncolytic adenovirus injection( BioTTT001 injection)

BioTTT001 is administered as a Intrathecal injection using an Ommaya reservoir.The dosage administered to the subjects is determined based on the group they belong to. This study establishes three dosage groups: 1.0×10\^9 VP, 5.0×10\^9 VP, and 1.0×10\^10 VP.In the first week, the drug is administered 3 times, followed by 1 dose every 3 weeks thereafter. In the phase Ib dose escalation study, participants can receive up to 6 doses, while in the phase II dose expansion study, participants will be treated until disease progression (PD), intolerable toxicity, the start of new anti-tumor treatment, termination of treatment decided upon careful consideration by the participant or investigator, death, or loss to follow-up (whichever occurs first).

干预措施: BioTTT001 injection