Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Supercharged immune cells injected into brain to fight tumors

NCT ID NCT02442297

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This early-phase trial tests a new approach for people with HER2-positive brain tumors that have come back or not responded to standard treatment. Researchers take the patient's own T cells, attach a special antibody (anti-HER2) to them, and inject these 'CAR T cells' directly into the brain. The goal is to find a safe dose and see if this can help fight the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HER2-specific CAR T cells
What this could lead to
If this works, it could point toward a new way to treat hard-to-cure brain tumors by using the patient's own immune cells to attack cancer.
What could go wrong
This is a very early, small phase 1 trial with only 10 participants, focused on safety and dosing. The CAR T cells may not last long in the body, and there is no guarantee they will shrink tumors or improve survival.

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

10 people

The number who actually took part.

Started

Apr 2016

Expected to finish

Apr 2037

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

3 years and older

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 at the time of procurement. * Recurrent or refractory HER2 positive primary central nervous system (CNS) tumor or HER2 positive tumor metastatic to the CNS. Patients in whom tumor resection (gross total or subtotal resection) is medically feasible can undergo surgery after procurement and prior to treatment. * Karnofsky/Lansky score of greater than or equal to 60 * Informed consent explained to, understood by and signed by subject/guardian. Subject/guardian given copy of informed consent Exclusion Criteria at the time of procurement: * Diagnosis of DIPG * Bulky tumors causing midline shift and/or symptoms/signs due to impending herniation * Known HIV positivity Treatment Inclusion criteria: * Recurrent or refractory HER2-positive\* primary CNS tumor or HER2-positive solid tumor metastatic to the CNS \* Immunohistochemistry (IHC) or RT-PCR will be used to determine HER2 positivity. Results will be compared to standard controls. HER2 expression in tumors on IHC should be greater than or equal to grade 1 and greater than or equal to 1+ intensity score. Wherein grades are defined as: Grade 0: no staining; Grade 1: 1-25%; Grade 2: 26-50% and Grade 3: 51-75% and Grade 4: 76-100% of cell staining for HER2 and intensity scores are: negative; 1+; 2+ and 3+ using breast cancer standard arrays as a guide for intensity. * Intracranial catheter (such as Rickham or Ommaya) in place * Age ≥ 3 years * Life expectancy ≥ 6 weeks * Karnofsky/Lansky score ≥ 60 * Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, ALT less than or equal to 5x upper limit of normal, serum creatinine less than or equal to 2x upper limit of normal for age, and Hgb greater than or equal to 7.0 g/dL * Pulse oximetry of greater than or equal to 90% on room air * Sexually active subjects must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion. The male partner should use a condom * Available autologous transduced T lymphocytes with greater than or equal to 15% expression of HER2 CAR determined by flow-cytometry and killing of HER2-positive targets greater than or equal to 20% in cytotoxicity assay * Patients who have undergone tumor resection should have recovered from the surgery. Patients with neurological deficits should have deficits that are stable for minimum of 1 week prior to treatment. * Subjects should have been off other investigational antineoplastic therapy for two weeks prior to CAR T cell infusion. Temozolomide will be allowed up to 48 hours pre-infusion. Dexamethasone up to a total dose of 2 mg per day will be allowed if medically indicated * Informed consent explained to, understood by and signed by research subjects/guardian. Subject/guardian given copy of informed consent. Treatment Exclusion Criteria: * Severe intercurrent infection * Known HIV positivity * Pregnant or lactating * History of hypersensitivity reactions to murine protein-containing products. * Diagnosis of DIPG * Steroid dose of dexamethasone greater than 2 mg per day (or equivalent)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Brain tumor, recurrent are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

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