Engineered immune cells take on deadly brain tumors
NCT ID NCT05241392
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a therapy made from a patient's own immune cells, engineered to target a protein called B7-H3 found on glioblastoma cells. The cells are delivered directly into the brain via a small device. The study aims to find a safe dose and check for any signs that the treatment shrinks tumors or helps patients live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- B7-H3-targeting CAR-T cells
- What this could lead to
- If this works, it could point toward a new treatment option for recurrent glioblastoma, a brain cancer with few effective therapies.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety, so effectiveness is uncertain. Risks include serious side effects like cytokine release syndrome and neurotoxicity.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Dec 2026
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 to 75 years
- 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: 1. Male or female, aged 18-75 years (including 18 and 75 years old); 2. Patients with relapsed glioblastoma, as confirmed by positron emission tomography (PET) or histologic pathology; 3. A \>= 30% staining extent of B7-H3 in his/her primary/recurrent tumor tissue by the immunochemical method; 4. Karnofsky scale score\>=50 5. Availability in collecting peripheral blood mononuclear cells (PBMCs) ; 6. Adequate laboratory values and adequate organ function; 7. Patients with childbearing/fathering potential must agree to use highly effective contraception; Exclusion Criteria: 1. Pregnant or breastfeeding females; 2. Contraindication to bevacizumab; 3. Within 5 days before the CAR-T cell infusion, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid); 4. Comorbid with Other uncontrolled malignancy; 5. Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection; 6. Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment; 7. Autoimmune diseases; 8. Receiving long-term immunosuppressive treatment after organ transplantation; 9. Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes; 10. Not recovered from the toxicities or side effects by previous treatment; 11. Subjects who have participated the other interventional trial within one month before the enrollment, or have received other CAR-T cell therapies or gene-modified cell therapy before enrollment. 12. Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures, the medical conditions including, but not limited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonary embolism, coagulation disorders, active systemic infection, uncontrolled infection et. al; or patients who are unwilling or unable to comply with the research procedures; these 13. Subjects with other conditions that would interfere trial participation at the investigator's discretion.
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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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Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a trio of repurposed drugs shrink recurrent brain tumors?
- Can an existing drug boost bevacizumab against recurrent brain cancer?
- One extra radiation dose after standard brain cancer therapy: can it boost the immune system?
- Radioactive tracer lights up Oxygen-Starved brain tumors
- Can a common virus vaccine help fight brain cancer?
- Radioactive tiles target brain tumors in frail patients