Actively Recruiting
Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001
Led by Henan Cancer Hospital · Updated on 2025-12-04
42
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years (inclusive)
- Diagnosed with non-small cell lung cancer confirmed by pathology
- Recurrent or progressive disease after standard treatment
- Tumor cells present in cerebrospinal fluid or MRI diagnosis of leptomeningeal metastasis
- Performance Status score of 3 or less
- Suitable for placement of an Ommaya reservoir for drug administration
- Expected survival of at least 3 months
- Good organ function including: adequate blood counts, coagulation, liver, and kidney function within specified limits
- Voluntary participation with signed informed consent
- Agreement to use effective contraception during treatment and for 6 months after last dose if of reproductive potential
- Negative pregnancy test within 7 days before first dose for women of reproductive potential
- Good compliance and willingness to follow all study procedures
- If previously treated with tyrosine kinase inhibitors for more than two weeks and have brain progression only, must continue current tyrosine kinase inhibitor treatment during enrollment
You will not qualify if you...
- Received systemic antitumor therapy within 2 weeks prior to first dose (including intravenous or intrathecal chemotherapy, whole-brain radiotherapy except immunotherapy)
- Received immunotherapy within 6 weeks prior to first dose
- Used traditional Chinese medicine with antitumor effects within 2 weeks prior to first dose
- Uncontrolled epilepsy
- Received any other investigational drug within 4 weeks prior to first dose
- Major organ surgery or significant trauma within 4 weeks prior to first dose, or scheduled elective surgery during study
- History of cell therapy, gene therapy, or oncolytic virus therapy
- Known or suspected allergies to study drug components or imaging contrast agents
- History or planned organ transplant during study
- Active infections requiring intravenous treatment or uncontrolled infections, or unexplained fever over 38.5°C during screening or before dosing
- Severe coagulation disorders or significant bleeding risk, recent gastrointestinal bleeding, or other grade 2 or higher bleeding events
- Received immunosuppressants within 14 days prior to first dose
- Unresolved adverse reactions from previous antitumor therapy above grade 1 (except alopecia)
- Immunodeficiency including HIV positive status
- Active hepatitis B or C, or positive syphilis antibody
- Poorly controlled hypertension despite treatment
- Severe cardiovascular disease or recent major cardiovascular events
- Other uncured malignancies within 3 years except certain precancerous conditions
- Active or recurrent autoimmune diseases except stable autoimmune thyroiditis
- Vaccination with live or recombinant vaccines within 4 weeks or inactivated vaccines within 2 weeks prior to first dose
- Previous immunotherapy with severe immune-related adverse events
- Brainstem metastases or rapidly progressing diffuse brain metastases
- Tumor invading ventricular walls or postoperative ventricular communication
- History of encephalitis, multiple sclerosis, or other CNS infections
- Cerebral herniation syndrome
- Alcohol or drug dependence
- Psychiatric disorders or poor compliance
- Pregnant or breastfeeding women
- Other serious systemic diseases or conditions judged unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
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, 450000
Actively Recruiting
Research Team
H
Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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