Can a Lab-Made protein restore immune defenses in glioma patients?
NCT ID NCT03687957
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether a drug called rhIL-7-hyFc can safely increase lymphocyte counts in people with high-grade glioma who have low immune cells after standard radiation and chemotherapy. About 42 participants will receive either the drug or a placebo by injection. The study first checks safety and dosing, then measures changes in immune cell levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rhIL-7-hyFc (a lab-made protein that may help increase immune cell counts)
- What this could lead to
- If it works, this could point toward a way to restore immune function in brain cancer patients, potentially helping them fight infections and better tolerate treatment.
- What could go wrong
- This is a very early, small trial (42 people) testing safety and immune effects, not whether it improves survival. The drug may cause side effects or fail to raise lymphocyte levels meaningfully.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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42 people
The number who actually took part.
- Started
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Jan 2019
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * World Health Organization (WHO) grade III, grade IV, and high risk grade II gliomas that require RT and TMZ treatment. * Phase 2 Expansion Cohort ONLY: Must be IDH1 wildtype, as defined by negative immunohistochemistry using an R132H-specific antibody and MGMT promoter unmethylated glioblastoma multiforme (WHO grade IV). * Post-operative treatment must have included radiation and TMZ. Prior Gliadel Wafers are allowed. Glucocorticoid therapy is allowed. Tumor treating fields (TTF) device is allowed. * Adequate organ and marrow function defined as follows: * Absolute neutrophil count ≥ 1,000/mcL * Platelets ≥ 75,000/mcL * Hemoglobin ≥ 8 g/dL * Total bilirubin ≤ 3.0 x institutional upper limit of normal * AST (SGOT)/ALT (SGPT) ≤ 3.0 × institutional upper limit of normal * Absolute lymphocyte count (ALC) ≥ 600/mcL (required for phase I and randomized phase II only) * Karnofsky Performance Status (KPS) ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others). * Able to provide written informed consent (or consent from a legally authorized representative). * Women of childbearing potential must have a negative serum pregnancy test prior to study entry (within 14 days). Patients must be willing to be on adequate contraception during treatment. * 18 years of age. Exclusion Criteria: * Receiving any other investigational agents which may affect patient's lymphocyte counts. * Pregnant women are excluded from this study because rhIL-7-hyFc has not been evaluated regarding its potential for teratogenic or abortifacients effects. There is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug, breastfeeding should be discontinued if the mother is treated with rhIL-7-hyFc. * Has an active viral infection requiring systemic treatment at screening. * Has active autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.,) that requires systemic treatment at the time of screening. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. * Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), Zoster, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed. * Has clinically significant cardiac enzymes (\[Tnl or TnT\] or CK-MD) * Patients with a clinically significant EKG on screening triggering a echocardiogram which is also clinically significant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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