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

NCT06763965 | Enrolling By Invitation Phase 1

• 1 other identifier: BJCT-01-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 glioma.

Conditions

Recurrent High-grade Glioma

Keywords

Oncolytic virus; IL-12; Adenovirus

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

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

  28 days within BioTTT001 injection

• DLT、MTD and/or RP2D

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

  28 days within BioTTT001 injection

• OS12

  12-month survival rate

  12 months

Study Arms (1)

BioTTT001 injection

EXPERIMENTAL

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.

Biological: BioTTT001 injection

Interventions

BioTTT001 injection BIOLOGICAL

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.

BioTTT001 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Beijing Bio-Targeting Therapeutics Technology Co., Ltd: lead

Study Sites (1)

Sanbo Brain Hospital, Capital Medical University

Beijing, Chaoyang District, China

Location

MeSH Terms

Conditions

Glioma; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: November 26, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2025-11

Locations

CN (1)