Off-the-Shelf immune cells aimed directly at deadly brain tumors

NCT ID NCT01082926

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 19, 2026 · Last updated Oct 20, 2026 · Updated 1 time

Summary

Researchers are testing a new cellular immunotherapy for people whose malignant glioma has come back after standard treatment. The treatment uses donor T cells that scientists have engineered to recognize a marker found on many glioma cells and to survive steroid treatment. Participants receive these cells, along with an immune-stimulating protein called aldesleukin, injected directly into the tumor. The main goal is to find out whether this approach is safe and to learn the best way to deliver it.

What this could mean

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

Active substance
Engineered donor T cells (GRm13Z40-2) given with aldesleukin (interleukin-2)
What this could lead to
If it works, this could point toward an off-the-shelf immune cell treatment that attacks recurrent brain tumors without waiting for a patient's own cells to be engineered.
What could go wrong
This is a very small phase 1 study focused on safety, so it may not show whether the treatment helps people live longer. Donor cells can be rejected by the body, and injecting them into the brain carries risks of swelling, bleeding, or infection.

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

6 people

The number who actually took part.

Started

Mar 2011

Finished

Sep 2013

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 70 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: * Histological verification of grade III or IV MG at original diagnosis * Radiographic evidence of progression/recurrence of the measurable disease more than 12 weeks after the end of radiation therapy * Expression of IL13Ralpha2 by immunohistochemistry * Karnofsky performance status (KPS) \>= 60 * Disease recurrence/progression in the cerebral hemisphere, which is in at least one area of enhancement amenable to biopsy after protocol enrollment in the following locations: * Adjacent or near previous resection cavity * Distant from primary location; this includes tumor spread to contralateral hemisphere, corpus callosum, thalamus, basal ganglion, or subependymal locations * Research participant has recovered from toxicity of prior therapies; an interval of at least 12 weeks must have elapsed since the completion of radiation therapy; at least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen; and at least 4 weeks since the completion of a non-nitrosourea-containing cytotoxic chemotherapy regimen; if a patient's most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of study treatment, with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting study treatment * History of prior treatment with Temodar if no evidence of intolerance; documentation of intolerance to Temodar is not required * Creatinine \< 1.6 * White blood cell (WBC) \>= 2,000/dl (or absolute neutrophil count \[ANC\] \> 1,000) Platelets \>= 100,000/dl unsupported by transfusion or growth factor, international normalized ratio (INR) \< 1.3 * Bilirubin \< 1.5 * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \< 2 X upper limits of normal * Female research participants of childbearing potential must not be pregnant as evidenced by a serum beta-HCG pregnancy test obtained within 7 days of enrollment * Research participants having reproductive potential must agree to use effective contraception during participation on this protocol * In the opinion of the neurosurgeon, research participant requires on-going dexamethasone therapy Exclusion Criteria: * Survival expectation less than 4 weeks * Pulmonary- Requirement for supplemental oxygen use that is not expected to resolve within 2 weeks, Cardiac- Uncontrolled cardiac arrhythmia, hypotension requiring pressor support, Renal- Dialysis dependent, Neurologic- refractory seizure disorder, clinically evident progressive encephalopathy * Tumors with the following characteristics: * Large tumor recurrence causing significant symptoms from brain shift or mass effect, and thus not requiring "decompressive" craniotomy * Tumors located primarily in the basal ganglion or thalamus * Tumors with significant involvement of midbrain, cerebellum, pons and medulla will be excluded due to neurological risks associated with edema exacerbation from therapy * Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible * Positive human immunodeficiency virus (HIV) serology based on testing within 4 weeks of enrollment * Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator * Failure to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study * History of ganciclovir and/or magnetic resonance imaging (MRI) contrast allergy or intolerance History of intolerance to IL-2

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Anaplastic astrocytoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • City of Hope

    Duarte, California, 91010, United States

More trials for these conditions

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