Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHenan Cancer Hospital

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • BioTTT001 injection

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators