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
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;
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;
Single group
BioTTT001 injection
Biological/VaccineBioTTT001 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.
DLT, MTD and/or RP2D
DLT, MTD and/or RP2D
Phase Ib dose-escalation study
DLT, MTD and/or RP2D;The incidence and severity of adverse events (AE) assessed based on the NCI CTCAE Version 5.0 standard.
Click on the lead sponsor to view all of their trials.
