OncoMatch/Clinical Trials/NCT07264569
Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001
Is NCT07264569 recruiting? Yes, currently enrolling (May 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
Disease stage
Metastatic disease required
Performance status
ECOG 0–3(Limited self-care)
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.
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