Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
This is a Phase 1, open-label, single-arm, dose-escalation and dose-expansion study to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary how well it works of YN003 Injection in patients with recurrent or progressive glioma. The study consists of Part A (dose escalation using a Bayesian Optimal Interval design) and Part B (dose expansion at the recommended Phase 2 dose).
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are YN003 Injection. The registry lists allocation as na. This is a Phase 1, open-label, single-arm, dose-escalation and dose-expansion study to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary how well it works of YN003 Injection in patients with recurrent or progressive glioma.
They plan to enroll about 50 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 1, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of YN003 Injection in Patients With Glioma
Interventions: YN003 Injection
Primary outcome (registry wording): To Incidence and characteristics of AEs/SAEs；
Who it is for (from inclusion criteria)
Ages 18 Years to 70 Years
Male or female subjects 18 years ≤ aged ≤ 70 years
Histologically confirmed recurrent or progressive glioma, including glioblastoma, as defined by the 2021 WHO Classification of Tumors of the Central Nervous System, Grade 3 to Grade 4, following standard therapy.Excluding re-irradiation for same lesions
Karnofsky Performance Status (KPS) ≥60
At least one measurable lesion per RANO 2.0 criteria
Have adequate hematologic, cardiac, hepatic, renal, coagulation, and pulmonary function at final screening
Have completed the required washout period for prior therapies before dosing on Day 1
Corticosteroid dose must be stable or tapering within 7 days prior to dosing
Who the registry excludes
Participation in another treatment clinical study within 1 month prior to the date when subject signed the consent form
Receipt of a live vaccine within 30 days prior to study treatment
Pregnant or breastfeeding women
Clinically significant intracranial hypertension (e.g., impending brain herniation or requiring urgent palliative intervention) or uncontrolled seizures. Subjects requiring antiepileptic drugs are eligible only if the dose has been stable for ≥ 14 days prior to first dosing
Toxicities from prior anticancer therapy that have not recovered to CTCAE v6.0 Grade ≤1, except for alopecia or other events considered tolerable by the investigator
Contraindications to MRI, including but not limited to pacemakers, epicardial pacing leads, infusion pumps, aneurysm clips, metal fragments, metallic prostheses, magnetic implants, intraocular metal objects, or non-removable metallic dental implants
Uncontrolled or severe cardiovascular or cerebrovascular disease
This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy.
Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.
Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07929909?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07929909?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.