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Recurrent High-grade GliomaPhase 1/2NCT06763965

Evaluating the Safety and Efficacy of BioTTT001 in Patients With Recurrent/Progressive High-grade Glioma.

A Phase 1/2 study testing BioTTT001 injection in people with Recurrent High-grade Glioma, run by Beijing Bio-Targeting Therapeutics Technology Co., Ltd at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study is a single-arm, open-label, dose-escalation and dose-expanding Phase Ⅰb/Ⅱ clinical study to evaluate the safety, tolerability, biodistribution characteristics and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in patients with recurrent/progressive high-grade… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent High-grade Glioma
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
30 participants
Where
1 siteChina
Study dates
26 Nov 2024to 31 Jul 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older, both male and female are eligible;
  • Patients with high-grade glioma who have recurred/progressed after receiving standard therapy as confirmed by histopathological confirmation meeting the 2021 World Health Organization (WHO) classification criteria for central nervous system tumors;
  • Karnofsky Performance Score (KPS) ≥ 60 points (see Appendix 2);
  • Suitable for placement of Ommaya sac as judged by the investigator to be eligible for administration;
  • Estimated survival ≥ 3 months;
  • Good organ function;
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  • Voluntary participation and ability to sign informed consent form prior to the start of study-related procedures, after explaining the content of the study;
  • Subjects of childbearing potential and sexually active partners must be willing to use a medically approved and effective method of contraception, such as a double-barrier method of contraception, during treatment and for 6 months after the last dose, and the male agrees not to donate sperm;
  • Females of childbearing potential, must have a negative blood pregnancy test result within 7 days prior to the first dose and be willing to undergo additional pregnancy tests during the study. Females of childbearing potential who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or are not postmenopausal; Menopause is the absence of menopause for 12 months in women over ≥ age of 45 and the exclusion of other causes of amenorrhea. In addition, serum follicle-stimulating hormone (FSH) levels in women under 50 years of age must be in the postmenopausal range for menopause to be confirmed;
  • Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.

Who cannot join

  • Received anti-tumor drug therapy such as radiotherapy, chemotherapy, biological therapy, endocrine therapy, targeted therapy and other anti-tumor drugs within 4 weeks before the first dose (excluding immunotherapy, nitrosourea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicines with anti-tumor indications);
  • Treatment with any other unmarketed investigational drug within 4 weeks prior to the first dose;
  • Surgical surgery of major organs within 4 weeks prior to the first dose (excluding live puncture) or have had significant trauma, or need to undergo elective surgery during the study;
  • Those who have a history of cell therapy, gene therapy, and oncolytic virus therapy in the past;
  • Those who have known or suspected hypersensitivity to the active ingredients of the study drug, excipients, and imaging contrast agents;
  • Those who have a history of organ transplantation or plan to undergo organ transplantation during the study;
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  • Patients with active infection or uncontrollable infection requiring intravenous systemic therapy, or fever of unknown cause > 38.5°C during the screening period and before the first dose;
  • Accompanied by severe coagulation disorder or other evidence of obvious bleeding risk; history of gastrointestinal bleeding; Any other ≥ CTCAE grade 2 bleeding event within the past 6 months;
  • Subjects who have received systemic corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days prior to the first dose; except in the following cases: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid treatments; short-term use of corticosteroids for prophylactic treatment (e.g., prevention of contrast agent allergy);
  • Adverse reactions from previous anti-tumor treatments have not yet recovered to ≤ Grade 1 according to CTCAE 5.0 (except for toxicities deemed to pose no safety risk by the investigator, such as hair loss, Grade 2 peripheral neuropathy, etc.);
  • History of immunodeficiency, including positive HIV antibody test;
  • Active hepatitis B (HBsAg positive and HBV-DNA > 500 IU/ml or lower limit of detection at the study center [only if the study center's detection limit is higher than 500 IU/ml]); active hepatitis C (HCV antibody positive and HCV-RNA > the detection limit at the study center), positive treponema pallidum antibody for syphilis;
  • Hypertension poorly controlled as judged by the investigator (arterial hypertension not controlled despite standard treatment: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
  • History of severe cardiovascular disease, such as: ventricular arrhythmia requiring clinical intervention; 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 administration; New York Heart Association (NYHA) functional class ≥II (see Appendix 4) or left ventricular ejection fraction (LVEF) <50%;
  • Presence of other untreated malignancies within the past 3 years or currently, except for carcinoma in situ that is considered clinically curable, such as in situ cervical cancer and basal cell carcinoma;
  • Active or past autoimmune diseases with potential for recurrence (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except clinically stable autoimmune thyroiditis;
  • Received live attenuated or recombinant vaccines within 4 weeks before first administration, or received inactivated vaccines within 2 weeks before first administration;
  • Previous immunotherapy with immune-related adverse events (irAE) of grade ≥3;
  • Tumorous lesions in the brainstem, cerebellum, posterior cranial fossa, or spinal cord, or presence of leptomeningeal disease;
  • Diffuse subependymal and subarachnoid space disease;
  • Patients whose lesions are closely related to the ventricles, posing a risk of intraventricular dissemination (patients judged by the investigator that the oncolytic virus cannot directly reach the ventricles after administration may be included);
  • History of encephalitis, multiple sclerosis, or other central nervous system infections;
  • Patients with brain herniation syndrome;
  • Known alcohol or drug dependence;
  • Patients with psychiatric disorders or poor compliance;
  • Pregnant or breastfeeding women;
  • Participants who, in the opinion of the investigator, have other serious systemic diseases or other reasons that make them unsuitable for participation 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.

China1 site

  • Sanbo Brain Hospital, Capital Medical University

    Beijing, Chaoyang District

Other trials in China

About this study

Official title: A Phase Ib/Ⅱ Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection With Recurrent/Progressive High-grade Glioma.

This study is a single-arm, open-label, dose-escalation and dose-expanding Phase Ⅰb/Ⅱ clinical study to evaluate the safety, tolerability, biodistribution characteristics and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in patients with recurrent/progressive high-grade glioma.

Read the detailed description

Phase Ⅰb Dose Escalation Study:Three dose groups were established in the dose escalation phase, namely 1.0×10^10 VP, 5.0×10^10 VP and 2.5×10^11 VP. The traditional "3+3" dose escalation method was used for dose escalation, with at least 3 subjects enrolled in each dose group, and each subject received only one corresponding dose until the MTD and/or RP2D were determined.It is planned to enroll 12~18 subjects, and the final sample size of enrollment depends on the number of DLT, the number of dose groups that are escalated before the DLT is observed, and the determination of the MTD.

Phase Ⅱ Dose Expansion Study:In this phase, one dose group was selected for a dose expansion study to further evaluate the efficacy and safety of BioTTT001 in patients with recurrent/progressive high-grade glioma.It is planned to select 1 dosage that may be used for phase Ⅰ clinical research to expand enrollment, and it is planned to enroll 10~30 subjects.

Being tested
BioTTT001 injection
Keywords
Oncolytic virus, IL-12, Adenovirus
Medical subject headings
Glioma, Adenoviridae Infections

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 multiple Intratumoral injection. The dose groups to be infusion were 1.0×10^10 viral particle (VP) ,5.0×10^10 VP and 2.5×10^11 VP based on the 3+3 dose escalation principle.

Study groups in NCT06763965
Study groupRoleWhat they receive
BioTTT001 injectionExperimentalBioTTT001 is administered as a multiple Intratumoral injection. The dose groups to be infusion were 1.0×10^10 viral particle (VP) ,5.0×10^10 VP and 2.5×10^11 VP based on the 3+3 dose escalation principle.
Receives: Biological: BioTTT001 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE5.0

    Measured: 28 days within BioTTT001 injection

  2. DLT、MTD and/or RP2D

    Maximum tolerated dose (MTD)、Dose-limiting toxicity（DLT）、Recommended Phase II Dose（RP2D）

    Measured: 28 days within BioTTT001 injection

  3. OS12

    12-month survival rate

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start26 Nov 2024
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06763965
Sponsor's protocol ID
BJCT-01-102
Status last verified
Nov 2025
First submitted
2 Jan 2025
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BioTTT001 injection in people with Recurrent High-grade Glioma, run by Beijing Bio-Targeting Therapeutics Technology Co., Ltd 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 10 inclusion and 27 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: enrolling by invitation, as of the sponsor's last update on 23 Mar 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: 28 days within BioTTT001 injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06763965.

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 23 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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