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Engineered immune cells take on deadly brain tumors

NCT ID NCT05241392

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.