Is NCT07346144 recruiting in Columbus, OH?

Yes, NCT07346144 is currently recruiting participants at its Columbus, OH location. This glioblastoma (gbm) clinical trial is actively enrolling qualified participants.

How do I join the glioblastoma (gbm) clinical trial in Columbus?

To join this clinical trial in Columbus, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Columbus clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Glioblastoma (GBM) Clinical Trial in Columbus, OH

About This Glioblastoma (GBM) Study in Columbus

The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and efficacy in patients with newly diagnosed or recurrent Glioblastoma. TGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response. One is herpes simplex virus thymidine kinase (HSV-tk), which converts the pro-drug valaciclovir into an active drug that can kill tumour cells and the other is interleukin 12 (IL-12), which activates the body's immune system to recognise and fight the tumour. Patients newly diagnosed with glioblastoma suitable for standard of care surgery and chemoradiotherapy or patients with recurrent glioblastoma suitable for further surgery may be eligible for the study. Patients will receive TGX-007 by a direct intratumoural injection and will then take the pro-drug valacyclovir orally for up to 21 days before proceeding to standard of care surgery. The study is split into two phases. Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose that will be used to further expand the study into Phase II. Phase II will expand the number of patients treated at the selected OBD to investigate how effective TGX-007 is at treating newly diagnosed and recurrent GBM. Approximately 68 people aged 18-70 will take part in the study.

Sponsor: Trogenix ltd

Who Can Participate

Inclusion Criteria

Aged 18-70 years

Karnofsky performance status ≥70

Newly diagnosed patients: Unifocal, unilateral high-grade glioma based on MRI

Recurrent patients: First radiological progression (as determined by the multidisciplinary team \[MDT\]) of GBM previously treated with standard care surgery and chemoradiotherapy. Patients must have a prior confirmed histological/molecular diagnosis of GBM

Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)

Debulking surgery is indicated for optimal patient care

Able to swallow oral medication

Willing to avoid live vaccines

Adequate organ function

Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to Day 0.

All patients must agree to practice true abstinence or to use highly effective contraception

Patient is willing and able to give informed consent for participation in the study

Exclusion Criteria

Patient who is pregnant, lactating or planning pregnancy during the course of the study

Immunodeficiency or active auto-immune disease requiring systemic therapy.

Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery

Live vaccine within 28 days prior to Day 0

Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0

History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection

Received previous treatment with a gene therapy

Significant history of a central nervous system disorder that, in the opinion of the Investigator, would preclude enrolment

Major surgery within 28 days prior to Day 0. A stereotactic biopsy is permitted

Known hypersensitivity or contraindications to valaciclovir, gadolinium, or any excipients for TGX-007

Contraindication to MRI with gadolinium

Any condition expected to interfere with the intended timing of debulking surgery

Previous non-glioma cancer within 3 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically stable, organ confined prostate cancer)

Any other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study

Patients who have participated in another research study involving an investigational product in the past 12 weeks or 5 half-lives of the product

Any psychological, familial, sociological, or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the study

Unwilling to allow their general practitioner, if appropriate, to be notified of participation in the study Newly diagnosed patients only:

Any prior therapy for glioma

Intended use of tumour treating fields Recurrent patients only:

Prior toxicities from anti-cancer agents or radiotherapy which have not recovered to ≤Grade 1 severity

Intended use of tumour treating fields

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbus?

Yes, this clinical trial (NCT07346144) has an active research site in Columbus, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Glioblastoma (GBM) Treatment Options in Columbus, OH

If you're searching for glioblastoma (gbm) treatment options in Columbus, OH, this clinical trial (NCT07346144) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbus research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced glioblastoma (gbm) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all glioblastoma (gbm) clinical trials near you to find additional studies recruiting in your area.

Glioblastoma (GBM) Clinical Trial in Columbus, OH

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