Is NCT06964737 recruiting in Columbus, OH?

Yes, NCT06964737 is currently recruiting participants at its Columbus, OH location. This recurrent malignant glioma clinical trial is actively enrolling qualified participants.

How do I join the recurrent malignant glioma 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.

Recurrent Malignant Glioma Clinical Trial in Columbus, OH

About This Recurrent Malignant Glioma Study in Columbus

This phase I trial tests the safety, side effects, and best dose of anti-glycoprotein-A repetitions predominant (GARP) chimeric antigen receptor (CAR) T cell therapy and how well it works in treating patients with grade III or IV gliomas that have come back after a period of improvement (recurrent). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as GARP, on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving anti-GARP CAR T cell therapy may be safe, tolerable, and/or effective in treating patients with recurrent grade III or IV gliomas.

Sponsor: Ohio State University Comprehensive Cancer Center

Who Can Participate

Inclusion Criteria

Patients are ≥ 18 years old

Capacity to understand and willingness to provide written informed consent

Diagnosis or clinical suspicion of recurrent malignant glioma, including:

History of high-grade glioma (World Health Organization \[WHO\] grade III or IV), or

Prior, histologically-confirmed diagnosis of grade II glioma with new radiographic findings consistent with a high-grade glioma

Imaging and/or histopathological confirmation of recurrent disease, or verification of "high risk" histology confirmed by a biopsy with measurable disease by the Radiologic Assessment in Neuro-Oncology (RANO) criteria

Patient has unifocal disease in one hemisphere and is supratentorial. Lesion and edema can not be located in eloquent locations (e.g., brainstem, pre-/post-central gyrus, visual cortex) or within 2 gyri of motor strip.

If on steroids such as dexamethasone, must be on a low dose (≤ 4mg per day) at the time of treatment, and not at an ascending dosage schedule at time of enrollment/leukapheresis

Prior to apheresis and treatment 1 a 2- week washout should be observed

Subjects must not have received bevacizumab therapy and are not planned to start such therapy

Karnofsky performance score (KPS) ≥ 60

Subject is a surgical candidate for surgery for malignant glioma with the intent of resecting \>80-90% of the tumor as the ideal treatment option

White blood cells (WBC) \> 4,000 cells/uL

Hemoglobin (Hgb) \> 7 gm/dL

Platelets (Plt) \> 100/dL

Serum creatinine ≤ 1.5 x institutional upper limit of normal

Liver function tests within 1.5 x institutional upper limit of normal

Women of reproductive potential must have a negative pregnancy test within 7 days of study start. All patients of reproductive potential must use a physician-approved contraceptive and refrain from sperm donation for at least two weeks prior, during, and six months after final T cell infusion. Women must refrain from breastfeeding for six months after final T cell infusion

Sufficient venous access, to be confirmed prior to apheresis

Life expectancy of greater than 12 weeks

PI clinical judgement of patients who will likely complete the trial and are able to maintain stable neurologic symptoms during intervention period

Exclusion Criteria

Patients who have a history of malignancy other than the glioma under investigation in this study, except patients with the following malignancies/treatment characteristics, who are eligible at the investigator's discretion:

Patients with a history of malignancy that has been treated with curative intent at least 2 years prior to screening and with no evidence of relapse, if no concurrent anti-cancer therapy (except hormonal therapy) is being given

Patients with a history of malignancy with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer

Patients who have prostate cancer with no evidence of metastatic disease and are not on active therapy, except anti-androgen therapy

History of autoimmune disease, or other diseases require long-term administration of high-dose steroids \[\> 10 mgs/day\] or immunosuppressive therapies

Research participants who received steroids must have either received their last dose of steroids 7 days or more prior to apheresis or have dosage tapered to \< 2mg/kg/day

Patients being treated concurrently (within 14 days prior to study enrollment) with any other investigational agent

Examples of other investigational agents that would be exclusionary include supportive care agents

Patients receiving anti-cancer agents such as chemotherapy (e.g., temozolomide) must stop treatment 14 days prior to undergoing apheresis and remain off therapy throughout the duration of CAR T therapeutic intervention

Patients with active fungal, bacterial, viral, or other infection that requires intravenous antimicrobials

Prophylactic antimicrobials are allowed

Patients with active invasive fungal infection should be excluded even if the treatment is oral antimicrobials

History of allergy to study products/diluents/emulsions

Recent history (within last 3 months) of uncontrolled seizures

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 (NCT06964737) 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.

Recurrent Malignant Glioma Treatment Options in Columbus, OH

If you're searching for recurrent malignant glioma treatment options in Columbus, OH, this clinical trial (NCT06964737) 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 clinical trial. You'll receive care from experienced recurrent malignant glioma 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 recurrent malignant glioma clinical trials near you to find additional studies recruiting in your area.

Recurrent Malignant Glioma Clinical Trial in Columbus, OH

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