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OH2 Oncolytic Viral Therapy in Central Nervous System Tumors

ConditionCentral Nervous System Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBinhui Biopharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old, male or female;

Phase I trials select pathologically confirmed recurrent central nervous system tumors (including but not limited to anaplastic astrocytoma, anaplastic oligoastrocytoma, glioblastoma, gliosarcoma, anaplastic ependymoma, Medulloblastoma, malignant meningioma, melanoma, etc.) postoperative patients; Phase IIa trial selects postoperative patients with pathologically confirmed recurrent glioblastoma

KPS score ≥60;

Partial or complete tumor resection, Ommaya reservoir has been placed in the operation area, and drug administration conditions are available;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • OH2 injection

    Biological/Vaccine

    OH2: Oncolytic Type 2 Herpes Simplex Virus

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Dose escalation and dose expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MTD (Maximum Tolerance dose)

If ≥2/6 subjects developed DLT, the previous dose group was MTD

Time frame
2 years
2

DLTs (Dose Limiting Toxicity)

Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol

Time frame
3 weeks from the first administration
3

Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)

All events with a Grade 3 or above toxicity (defined by the CTCAE v5.0) will be tabulated by event and by relationship to OH2.

Time frame
2 years

Secondary outcomes

1

OS (Overall Survival)

The overall survival for each patient receiving OH2 will be calculated.

Time frame
2 years
2

PFS (Progression Free Survival)

Time after OH2 administration to clinical and radiographic disease progression will be evaluated.

Time frame
2 years
3

Biodistribution and viral shedding

OH2 DNA copy

Time frame
2 years
4

Immunogenicity

HSV-2 antibody

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Binhui Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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