RecruitingPhase 1Phase 2NCT07264569

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

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


Sponsor

Henan Cancer Hospital

Enrollment

42 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called BioTTT001 delivered directly into the fluid around the brain and spinal cord. It is designed for people with non-small cell lung cancer (NSCLC) that has spread to the lining of the brain — a serious condition called leptomeningeal metastasis. **You may be eligible if...** - You are between 18 and 70 years old - You have NSCLC confirmed by biopsy that has spread to the fluid around the brain, confirmed by MRI or spinal fluid analysis - Your cancer continued to progress after standard treatments - Your doctor believes you are suitable for a device called an Ommaya reservoir (a small device placed under the scalp to deliver medication) - Your liver, kidneys, and blood counts are within acceptable ranges - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have uncontrolled seizures - You have brainstem tumors or rapidly spreading brain involvement - You have had serious bleeding events or blood clotting disorders - You have active serious infections or uncontrolled HIV, hepatitis B, or hepatitis C - You have a history of organ transplantation - You are pregnant or breastfeeding - You have received systemic cancer treatment (not including immunotherapy) within the past 2 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBioTTT001 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.


Locations(1)

Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in the Treatment of Patients With Recurrent/Progressive Non-s

Zhengzhou, Henan, China

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NCT07264569


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