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New treatment option for Recurrent Malignant Glioma
Official title Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas
ClinicalTrials.gov ID: NCT06964737
What this study is testing
What is Anti-GARP Chimeric Antigen Receptor-T Cells?
Anti-GARP Chimeric Antigen Receptor-T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent malignant glioma.
Also referred to as Anti-GARP CAR T Cells (SY), Anti-GARP CAR T-cells (SY).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Patients who have a history of malignancy other than the glioma under investigation in this study, except patients with the following...
- 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...
- 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...
- 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...
See the full eligibility 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
- people 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...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.