Meningeal MetastasisPhase 1/2NCT07264569
Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001
A Phase 1/2 study testing BioTTT001 injection in people with Meningeal Metastasis, run by Henan Cancer Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meningeal Metastasis
- What is being tested?
- BioTTT001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 30 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Expected survival ≥ 3 months;
- Good organ function, defined as follows:
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- Blood routine (not having received blood transfusion or other treatments within 14 days): 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;
- Coagulation function: Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN), International Normalized Ratio (INR) ≤ 1.5 times ULN;
- Liver function: Total bilirubin (TBIL) ≤ 1.5 times ULN, Gilbert's syndrome participants should be ≤ 3 times ULN, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times ULN (if there is liver metastasis, ALT or AST ≤ 5 times ULN);
- Renal function: Serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault formula calculation see Appendix 3);
- Voluntarily participate and sign the informed consent form after being explained the study content before the start of the relevant procedures;
- For participants and partners with reproductive capacity and sexual activity, must agree to use medically approved effective contraception methods during treatment and for 6 months after the last dose, such as double-barrier contraception, and men agree not to donate sperm;
- For women with reproductive capacity, the blood pregnancy test result within 7 days before the first dose must be negative, and willing to undergo additional pregnancy tests during the study. Reproductive capacity refers to women who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or are not postmenopausal; Menopause is defined as amenorrhea ≥ 12 months in women over 45 years old, excluding other causes of amenorrhea. Additionally, for women under 50 years old, serum Follicle-Stimulating Hormone (FSH) levels must be in the postmenopausal range to confirm menopause;
- Good compliance, willing and able to follow all study procedures and cooperate with observation and follow-up.
- If patients have previously received tyrosine kinase inhibitors (TKIs) treatment for more than two weeks and have only brain progression, they should continue the TKIs treatment during the enrollment period and cannot arbitrarily switch to other TKIs.
Who cannot join
- 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;
- those who received any other investigational drug within 4 weeks prior to the first dose;
- major organ surgeries (excluding biopsy) or significant trauma within 4 weeks prior to the first dose, or those requiring elective surgery during the study;
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- patients with prior history of cell therapy, gene therapy, or oncolytic virus therapy;
- individuals with known or suspected allergies to active ingredients, excipients, or contrast agents in the study drug or imaging contrast agents;
- patients with organ transplant history or planned organ transplant during the study;
- active infections requiring systemic intravenous treatment or uncontrolled infections, or unexplained fever>38.5℃ occurring during screening or before the first dose;
- patients with severe coagulation disorders or evidence of significant bleeding risk; history of gastrointestinal bleeding; any other CTCAE 2-level or higher bleeding events within 6 months;
- participants who received immunosuppressants (e.g., azathioprine, cyclophosphamide, methotrexate, thalidomide) within 14 days prior to the first dose;
- patients whose adverse reactions from previous antitumor therapy have not resolved to a CTCAE 5.0 grade ≤1 (excluding non-safety-related toxicities like alopecia as determined by investigators);
- patients with immunodeficiency history, including HIV antibody-positive status;
- Active hepatitis B (HBsAg-positive with HBV-DNA> 500 IU/mL or laboratory test lower limit [only when the laboratory test lower limit exceeds 500 IU/mL]); Active hepatitis C (HCV antibody positive with HCV-RNA> laboratory test lower limit); Positive Treponema pallidum antibody;
- Hypertension poorly controlled by investigators (uncontrolled arterial hypertension despite standardized treatment: systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100 mmHg);
- History of severe cardiovascular disease: such as clinically managed ventricular arrhythmias; QTc interval> 480 ms; Acute coronary syndrome, congestive heart failure, stroke, or other Grade III or higher cardiovascular events within 6 months prior to first dose; New York Heart Association (NYHA) class II or left ventricular ejection fraction (LVEF) <50%;
- Concurrent presence of other uncured malignancies within 3 years (excluding clinically curable precancerous conditions like cervical carcinoma in situ and basal cell carcinoma);
- Active or recurrent autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) except clinically stable autoimmune thyroiditis;
- Vaccination history within 4 weeks prior to first dose (live attenuated vaccines/recombinant vaccines) or within 2 weeks prior to first dose (inactivated vaccines);
- Previous immunotherapy with irAE grade ≥3;
- Patients with intracranial brainstem metastases or rapidly progressing diffuse cerebral parenchymal metastases;
- those showing tumor enhancement margins invading ventricular walls on cranial MRI or postoperative ventricular communication;
- history of encephalitis, multiple sclerosis, or other CNS infections;
- cerebral herniation syndrome;
- confirmed alcohol/drug dependence;
- psychiatric disorders or poor compliance;
- Pregnant or lactating women;
- Researchers believe that due to other serious systemic diseases or other reasons, the subjects are not suitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee contact
China1 site, 1 recruiting
- Recruiting
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, 450000
Chen Lijuan Chen Lijuan, 0371-65588251, hnszlyyyb@163.com
About this study
Official title: 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
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
Read the detailed description
This study is a single-arm, open-label, dose-escalation and dose-expansion phase Ib/II clinical trial aimed at evaluating the safety, tolerability, biological distribution characteristics, and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in patients with recurrent/progressive non-small cell lung cancer with meningeal metastases. The study is divided into two phases: the phase Ib dose-escalation .The dose escalation phase establishes three dosage groups, namely 1.0×10^9 VP, 5.0×10^9 VP, and 1.0×10^10 VP and the phase II dose-expansion.
- Conditions
- Meningeal Metastasis
- Being tested
- BioTTT001 injection
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioTTT001 injectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human nsIL12 oncolytic adenovirus injection( BioTTT001 injection) | Experimental | 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.In the first week, the drug is administered 3 times, followed by 1 dose every 3 weeks thereafter. In the phase Ib dose escalation study, participants can receive up to 6 doses, while in the phase II dose expansion study, participants will be treated until disease progression (PD), intolerable toxicity, the start of new anti-tumor treatment, termination of treatment decided upon careful consideration by the participant or investigator, death, or loss to follow-up (whichever occurs first). Receives: Biological: BioTTT001 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT, MTD and/or RP2D
DLT, MTD and/or RP2D
Measured: Progress-free survival time
Phase Ib dose-escalation study
DLT, MTD and/or RP2D;The incidence and severity of adverse events (AE) assessed based on the NCI CTCAE Version 5.0 standard.
Measured: 28 days within BioTTT001 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start25 Jun 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningeal MetastasisStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264569
- Sponsor's protocol ID
- HXNY-BM-01
- Status last verified
- Dec 2024
- First submitted
- 19 May 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07264569
- Acronym / sponsor ID
- HXNY-BM-01
- Conditions
- Meningeal Metastasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is a single-arm, open-label, dose-escalation and dose-expansion phase Ib/II clinical trial aimed at evaluating the safety, tolerability, biological distribution characteristics, and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in patients with recurrent/progressive non-small cell lung cancer with meningeal metastases. The study is divided into two phases: the phase Ib dose-escalation .The dose escalation phase establishes three dosage groups, namely 1.0×10^9 VP, 5.0×10^9 VP, and 1.0×10^10 VP and the phase II dose-expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant human nsIL12 oncolytic adenovirus injection( BioTTT001 injection) | Experimental | Biological: BioTTT001 injectionBioTTT001 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.In the first week, the drug is administered 3 times, followed by 1 dose every 3 weeks thereafter. In the phase Ib dose escalation study, participants can receive up to 6 doses, while in the phase II dose expansion study, participants will be treated until disease progression (PD), intolerable toxicity, the start of new anti-tumor treatment, termination of treatment decided upon careful consideration by the participant or investigator, death, or loss to follow-up (whichever occurs first). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
- Expected survival ≥ 3 months;
Key exclusion criteria (29 listed)
- 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;
- those who received any other investigational drug within 4 weeks prior to the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioTTT001 injectionBioTTT001 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. | Biological | Recombinant human nsIL12 oncolytic adenovirus injection( BioTTT001 injection) |
Primary outcome
DLT, MTD and/or RP2D
Time frame: Progress-free survival time
DLT, MTD and/or RP2D
Phase Ib dose-escalation study
Time frame: 28 days within BioTTT001 injection
DLT, MTD and/or RP2D;The incidence and severity of adverse events (AE) assessed based on the NCI CTCAE Version 5.0 standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BioTTT001 injection in people with Meningeal Metastasis, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee (0371-65588251, dingjing201305@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT, MTD and/or RP2D (time frame: Progress-free survival time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.