A Prospective, Single-arm Clinical Study on the Safety and Efficacy of Ivoximab Combined With Temozolomide in the Treatment of Relapsed/Refractory Glioma

A Prospective, Single-arm Clinical Study on the Safety and Efficacy of Ivoximab Combined With Temozolomide in the Treatment of Relapsed/Refractory Glioma

This study is a prospective, single-arm clinical trial aimed at evaluating the safety and efficacy of ivoximab combined with temozolomide in the treatment of relapsed/refractory glioma. The study plans to enroll 29 patients with relapsed/refractory glioma. After signing informed consent and meeting the inclusion/exclusion criteria through screening, patients will receive treatment with ivoximab combined with temozolomide. Efficacy evaluation will be conducted every two treatment cycles using the Response Assessment in Neuro-Oncology (RANO 2.0) criteria, and treatment will continue until disease progression or intolerance to the combined regimen.

Inclusion Criteria:

• Relapsed/refractory glioma confirmed by histology and clinical imaging; ECOG performance status score of 0-1; Expected survival time ≥ 6 months; Adequate organ function, as demonstrated by meeting the following laboratory parameters; For female subjects of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Cycle 1, Day 1), and the result must be negative. If the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required. A female of non-childbearing potential is defined as being postmenopausal for at least one year, or having undergone surgical sterilization or hysterectomy； If there is a risk of pregnancy, all subjects (both male and female) must use contraceptive measures with a failure rate of less than 1% per year throughout the entire treatment period until 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy).

Exclusion Criteria:

• Diagnosis of another malignancy within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ); Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); Receipt of systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first dose; Active autoimmune disease requiring systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; Receipt of systemic glucocorticoid therapy (excluding nasal spray, inhaled, or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose; Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted; Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; Known allergy to any drug used in this study; Presence of factors affecting oral administration of temozolomide (e.g., inability to swallow, intestinal obstruction, etc.); Failure to fully recover from toxicity and/or complications caused by any previous intervention prior to the start of treatment (i.e., ≤ Grade 1 or return to baseline, excluding fatigue or alopecia); Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy number above the upper limit of normal of the testing center's laboratory); Subjects with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); Receipt of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated influenza vaccines administered by injection for seasonal influenza are permitted within 30 days prior to the first dose; however, intranasal live attenuated influenza vaccines are not permitted.

Pregnant or breastfeeding women; Presence of any severe or uncontrolled systemic disease; Evidence of medical history or disease, treatment, or abnormal laboratory values that may interfere with the study results or prevent the subject from fully participating in the study, or other conditions deemed by the investigator as unsuitable for enrollment, including potential risks that the investigator believes would make participation in this study inappropriate.