OH2 Oncolytic Viral Therapy in Central Nervous System Tumors

  • STATUS
    Recruiting
  • End date
    Jun 15, 2025
  • participants needed
    28
  • sponsor
    Wuhan Binhui Biotechnology Co., Ltd.
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Updated on 22 March 2022
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Summary

In the first phase, it mainly explores the safety, tolerability and preliminary effectiveness of two doses of OH2 injection in the treatment of patients with recurrent central nervous system tumors; to evaluate the biodistribution and virus shedding of OH2 injection administered in the tumor cavity; to evaluate the level of anti-HSV2 antibody in patients when OH2 injection is administered intracavitary to tumor; to determine the phase II recommended dose (RP2D) of OH2 injection in the treatment of recurrent glioblastoma.

Phase IIa, to evaluate the preliminary efficacy of OH2 injection in the treatment of patients with recurrent glioblastoma after surgery, and to further evaluate the safety of OH2 in the treatment of relapsed glioblastoma.

Details
Condition Central Nervous System Tumors
Treatment OH2 injection
Clinical Study IdentifierNCT05235074
SponsorWuhan Binhui Biotechnology Co., Ltd.
Last Modified on22 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

a)
HBV viral load before the first dose The amount must be less than 1000 copies/ml (200
IU/ml), and subjects should receive anti-HBV treatment throughout the trial drug treatment
period to avoid viral reactivation; b) For anti-HBc (+), HBsAg (-), anti-HBs ( -) and viral
load (-) subjects, do not require prophylactic anti-HBV therapy, but require close
monitoring for viral reactivation
Cardiovascular disease meets any of the following: a. Congestive heart failure with
cardiac function ≥ NYHA class III; b. Serious arrhythmia requiring drug treatment; c. Acute
myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery
bypass, or stenting occurred within 6 months before the first administration; d. Left
ventricular ejection fraction (EF) < 60%; e. QTcF interval > 450 ms in men, > 470 ms in
women, or risk factors for torsades de pointes such as clinically significant hypokalemia
family history of long QT syndrome, or family history as judged by the investigator History
of arrhythmias (eg, pre-excitation syndrome); f. Uncontrolled hypertension (defined as
systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg after
standardized antihypertensive drug treatment)
Subjects with active autoimmune disease or a history of autoimmune disease but may
relapse, but subjects with the following diseases are not excluded and can be further
screened: a. Type 1 diabetes; b. Hypothyroidism (if controllable with hormone replacement
therapy alone); c. controlled celiac disease; d. Skin diseases that do not require systemic
treatment (eg vitiligo, psoriasis, alopecia); e. Any other disease that will not recur in
the absence of external triggers
Subjects with unstable mental illness, alcohol, drug or substance abuse. 14. Female
subjects who are pregnant or breastfeeding, or who are expected to become pregnant during
the trial period (from the screening visit until 180 days after dosing) and male subjects
who are expected to conceive their partner
The adverse reactions of previous anti-tumor therapy have not recovered to (CTCAE 5.0)
grade 1 (except for alopecia)
The investigator determines that he has a serious uncontrollable disease, or there are
other conditions that may affect the acceptance of the treatment in this study, and are
considered unsuitable to participate in this researcher
Other investigators deem it unsuitable for enrollment

Exclusion Criteria

28 days before enrollment, subjects participated in other clinical trial
projects
The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28
days before the first use of the test drug
The subjects have received traditional Chinese medicine, modern Chinese medicine
preparations and antiviral drugs within 7 days before using the test drug for the first
time
Subjects had received radiotherapy to the brain 3 months before their first use of the
test drug
Subjects with other active extracranial malignancies requiring concomitant therapy
Subjects known to be allergic to the test drug or its active ingredients, excipients, and
imaging contrast agents
Subjects who are going to undergo or have received tissue/organ transplantation in the
past
The subject has active infection or unexplained fever >38.5℃ during the screening period
and before the first dose
Subjects with active pulmonary tuberculosis (TB) who are receiving anti-tuberculosis
treatment or who have received anti-tuberculosis treatment within 1 year before screening
Anti-HIV(+) or anti-HCV(+) or specific antibody (TPHA) positive or active hepatitis B
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