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Virus Therapy
Virus-Based Drug Therapy for Brain Tumor (rQNestin Trial)
Phase 1
Recruiting
Led By E. Antonio Chiocca, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Frozen biopsy consistent with glioma by neuropathologist at the time of the first surgery in this longitudinal trial
Participants must have prior diagnosis of IDH wild-type glial tumor including GBM, grade 3 anaplastic astrocytoma or oligodendroglioma or grade 2 astrocytoma with genetic features consistent with GBM, as confirmed by a neuropathologist or by a previous local pathology report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated every 2 months for 1 year
Awards & highlights
rQNestin Trial Summary
This trial is testing the safety of a new virus-based drug for brain tumors. If it is safe, they will also test what dose is most effective.
Who is the study for?
Adults over 18 with recurrent brain tumors who've had prior radiation and chemotherapy, have a Karnofsky Performance Score ≥70, and can tolerate multiple biopsies. They must not be pregnant or breastfeeding, agree to use contraception, and have no severe infections or immune disorders. Tumors must meet specific size/location criteria.Check my eligibility
What is being tested?
The trial is testing rQNestin34.5v.2, an investigational oncolytic virus for safety and proper dosage against recurrent malignant glioma. It includes cyclophosphamide treatment and stereotactic biopsy in a Phase I clinical setting.See study design
What are the potential side effects?
Potential side effects may include typical reactions to viruses such as fever, fatigue, headache; possible local effects at the injection site; immune responses like inflammation; plus any side effects from cyclophosphamide like nausea or low blood cell counts.
rQNestin Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My first surgery biopsy confirmed I have glioma.
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I have been diagnosed with a specific type of brain tumor that is not IDH mutant.
Select...
I have received temozolomide with radiation as standard treatment before.
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My blood, kidney, and liver tests are normal.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I still have some tumor left or this is my first or second time cancer has come back.
Select...
I am 18 years old or older.
Select...
My MRI shows my cancer meets specific size and location criteria.
rQNestin Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated every 2 months for 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated every 2 months for 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
HSV1 Antibody Response
HSV1 Viremia
MRI Changes in Flow
+3 moreSide effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
rQNestin Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C- Multiple Dose rQNestinExperimental Treatment2 Interventions
Arm C includes up to 6 intratumoral repeated doses of rQNestin34.5v.2, first in a cohort receiving 10^8 pfus per time point, followed by a cohort receiving 10^9 or 10^7 pfus per time point.
Arm C adds 2 cohorts of 12 subjects in an open-label clinical trial of rQNestin34.5v.2 administered at two dose levels
The injections are planned for days 0, 15, 30, 60, 90, and 120
Subjects with presumed radiologic evidence of recurrent malignant glioma will undergo stereotactic biopsy under monitored general or local anesthesia. Evidence of recurrent high grade or malignant must be found on frozen section for the person to receive administration of the agent.
Group II: Arm B- rQNestin+CPAExperimental Treatment3 Interventions
Arm B is rQNestin34.5v.2 treatment with Cyclophosphamide (CPA) pre-treatment This study follows a standard 3+3 dose escalation design. Participants will not enroll to Arm B until the MTD or HTD has been met for Arm A.
Cyclophosphamide one intravenous injection 2 days prior to procedure.
Subjects with presumed radiologic evidence of recurrent malignant glioma will undergo stereotactic biopsy under monitored general or local anesthesia. Evidence of recurrent high grade or malignant must be found on frozen section for the person to receive administration of the agent.
rQNestin34.5v.2 Indicated dose as per cohort, Intratumor administration during surgery, single dose
Group III: Arm A- rQNestinExperimental Treatment2 Interventions
Arm A is rQNestin34.5v.2 treatment This study follows a standard 3+3 dose escalation design. Participants will not enroll to Arm B until the MTD or HTD has been met for Arm A.
Subjects with presumed radiologic evidence of recurrent malignant glioma will undergo stereotactic biopsy under monitored general or local anesthesia. Evidence of recurrent high grade or malignant must be found on frozen section for the person to receive administration of the agent.
rQNestin34.5v.2 Indicated dose as per cohort, Intratumor administration during surgery, single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,924 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,437 Total Patients Enrolled
Candel Therapeutics, Inc.Industry Sponsor
11 Previous Clinical Trials
1,211 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic infection with HIV, hepatitis B, or C.I am currently being treated for an active infection.I have had cancer that needed treatment beyond surgery in the last 2 years.My tumor size or location does not exclude me from the trial.I have not taken immunosuppressive drugs in the last 6 months.I have an active tuberculosis infection.I haven't had severe bleeding in the last 6 months.I do not have any uncontrolled illnesses.My first surgery biopsy confirmed I have glioma.I have been diagnosed with a specific type of brain tumor that is not IDH mutant.I had radiation therapy with a high dose on my tumor more than 4 weeks ago.I have received temozolomide with radiation as standard treatment before.My blood, kidney, and liver tests are normal.I am able to care for myself but may not be able to do active work.I have a bleeding disorder or had significant bleeding in the last year.I have been treated with drugs targeting VEGF or VEGFR.I am currently being treated for an active HSV-1 infection.I have a condition that weakens my immune system.I have recovered from major side effects of my previous treatments.I still have some tumor left or this is my first or second time cancer has come back.I haven't taken dexamethasone in the last 14 days.I am 18 years old or older.I need continuous blood thinners that can't be stopped for surgery or biopsy.My MRI shows my cancer meets specific size and location criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C- Multiple Dose rQNestin
- Group 2: Arm A- rQNestin
- Group 3: Arm B- rQNestin+CPA
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA authorized rQNestin for usage?
"Data on rQNestin's safety and efficacy is limited, thus warranting a score of 1 according to the team at Power."
Answered by AI
Have there been any other experimental trials involving rQNestin?
"Presently, 816 clinical studies of rQNestin are ongoing. Of those trials, 154 have reached Phase 3 and the majority are located in Philadelphia, PA; however there are 27825 sites globally conducting research with this medication."
Answered by AI
To what diseases is rQNestin typically administered?
"rQNestin has proven to be a successful therapeutic intervention for multiple sclerosis, mixed-cell type lymphoma, and myelocytic acute leukemia."
Answered by AI
Is this research effort presently recruiting participants?
"Clinicaltrials.gov confirms that this study is actively in search of participants, with the initial listing posted on July 18th 2017 and most recently edited October 24th 2022."
Answered by AI
How extensive is the participant population of this clinical experiment?
"Affirmative. Clinicaltrials.gov shows that the medical study, initially listed on 18th July 2017, is currently recruiting patients and requires 62 people at two different sites to partake in this experiment."
Answered by AI
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