OncoMatch/Clinical Trials/NCT07264569
Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001
Is NCT07264569 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies BioTTT001 for meningeal metastasis.
Treatment: BioTTT001 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Disease stage
Metastatic disease required
Performance status
ECOG 0–3(Limited self-care)
Demographics
Prior therapy
Must have received: standard treatment
who have experienced recurrence or progression after standard treatment
Cannot have received: systemic antitumor therapy
Exception: excluding immunotherapy
Patients who have received systemic antitumor therapy within two weeks, including intravenous chemotherapy, intrathecal chemotherapy, or whole-brain radiotherapy (excluding immunotherapy)
Cannot have received: immunotherapy
immunotherapy administered within 6 weeks prior to the first dose
Cannot have received: traditional Chinese medicine with antitumor indications
traditional Chinese medicine with antitumor indications administered within 2 weeks prior to the first dose
Cannot have received: investigational drug
those who received any other investigational drug within 4 weeks prior to the first dose
Cannot have received: cell therapy
patients with prior history of cell therapy
Cannot have received: gene therapy
patients with prior history of gene therapy
Cannot have received: oncolytic virus therapy
patients with prior history of oncolytic virus therapy
Cannot have received: immunotherapy with irAE grade ≥3
Previous immunotherapy with irAE grade ≥3
Lab requirements
Blood counts
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
Kidney function
Serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin (TBIL) ≤ 1.5 times ULN, Gilbert's syndrome participants ≤ 3 times ULN, AST and ALT ≤ 3 times ULN (if liver metastasis, ALT or AST ≤ 5 times ULN)
Good organ function, defined as follows: ... (see full text for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07264569 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic antitumor therapy, immunotherapy, traditional Chinese medicine with antitumor indications disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify