RECRUITING

Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas

Talk to us

Conditions

Recurrent Malignant GliomaRecurrent WHO Grade 3 GliomaRecurrent WHO Grade 4 GliomaWHO Grade 2 GliomaWHO Grade 3 GliomaWHO Grade 4 Glioma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I, Dose-Escalation Trial of Anti-GARP Chimeric Antigen Receptor-T Cell Therapy in Patients With Recurrent High-Grade Glioma Treated at a Single Medical Center

Quick Facts

Study Start:2025-07-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06964737

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients are ≥ 18 years old
  2. * Capacity to understand and willingness to provide written informed consent
  3. * Diagnosis or clinical suspicion of recurrent malignant glioma, including:
  4. * History of high-grade glioma (World Health Organization \[WHO\] grade III or IV), or
  5. * Prior, histologically-confirmed diagnosis of grade II glioma with new radiographic findings consistent with a high-grade glioma
  6. * 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
  7. * Disease in one hemisphere and is supratentorial
  8. * 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
  9. * Subjects must not have received bevacizumab therapy and are not planned to start such therapy
  10. * Karnofsky performance score (KPS) ≥ 60
  11. * Surgical candidate for surgery for malignant glioma
  12. * White blood cells (WBC) \> 4,000 cells/uL
  13. * Hemoglobin (Hgb) \> 7 gm/dL
  14. * Platelets (Plt) \> 100/dL
  15. * Serum creatinine ≤ 1.5 x institutional upper limit of normal
  16. * Liver function tests within 1.5 x institutional upper limit of normal
  17. * 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
  18. * Sufficient venous access, to be confirmed prior to apheresis
  1. * 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:
  2. * 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
  3. * 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
  4. * Patients who have prostate cancer with no evidence of metastatic disease and are not on active therapy, except anti-androgen therapy
  5. * History of autoimmune disease, or other diseases require long-term administration of high-dose steroids \[\> 10 mgs/day\] or immunosuppressive therapies
  6. * 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
  7. * Patients being treated concurrently (within 14 days prior to study enrollment) with any other investigational agent
  8. * Examples of other investigational agents that would be exclusionary include supportive care agents
  9. * 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
  10. * Patients with active fungal, bacterial, viral, or other infection that requires intravenous antimicrobials
  11. * Prophylactic antimicrobials are allowed
  12. * Patients with active invasive fungal infection should be excluded even if the treatment is oral antimicrobials
  13. * History of allergy to study products/diluents/emulsions

Contacts and Locations

Study Contact

Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCclinicaltrials@osumc.edu

Principal Investigator

James B Elder, MD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • James B Elder, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Malignant Glioma
  • Recurrent WHO Grade 3 Glioma
  • Recurrent WHO Grade 4 Glioma
  • WHO Grade 2 Glioma
  • WHO Grade 3 Glioma
  • WHO Grade 4 Glioma