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Brain cancer breakthrough? CAR t cells injected directly into fluid around brain in new trial

NCT ID NCT05625594

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new approach to treat central nervous system (CNS) lymphoma by injecting specially engineered immune cells (CAR T cells) directly into the fluid surrounding the brain. The study involves 20 participants and aims to find the safest dose while monitoring side effects and tumor response. If it works, this method could offer a more targeted way to fight cancer in the brain.

What this could mean

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

Active substance
CD19-targeting CAR T cells (genetically modified immune cells)
What this could lead to
If successful, this could provide a new treatment option for CNS lymphoma by delivering cancer-fighting cells directly to the brain.
What could go wrong
This is an early phase 1 trial with only 20 participants, so safety and effectiveness are not yet proven. There are risks of 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 20 people

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

Started

Jun 2023

Expected to finish

May 2028

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 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: * Participant must have the ability to understand and the willingness to sign a written informed consent * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed. However, the research participant can proceed with lymphodepletion (if applicable) and CAR T cell infusion only after the translated full consent form is signed * Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable exceptions may be granted with study principal investigator (PI) approval * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 * Documented primary CNS lymphoma. Progression must be determined radiographically. Participant must have measurable disease which could be a measurable lymphomatous mass or, in the case of leptomeningeal only disease, measurable lymphoma cells in CSF by flow cytometry * Patients with secondary CNS lymphoma with CNS only relapse, confirmed by PET-CT, may also be eligible, per PI discretion. * Documented current CD19+ tumor expression if prior CD19 directed therapy was used * Participant must have received and failed or have been intolerant to CNS directed therapy like high dose methotrexate or high dose cytarabine based regimens. Participants are not required to have failed all of these agents if, in the investigator's opinion, they would benefit from treatment on the current protocol * Prior CAR T cell therapy is allowed if at least 3 months have elapsed prior to leukapheresis procedure * If participant received prior CD19-CAR T cells persistence must be evaluated and found to be \<5% prior to leukapheresis procedure * No known contraindications to leukapheresis, steroids or tocilizumab * Participant of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment * Total serum bilirubin =\< 2.0 mg/dL (within 14 days of signing the screening and leukapheresis consent) * Patients with Gilbert syndrome may be included if their total bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\< 1.5 x ULN * Aspartate aminotransferase (AST) =\< 2.5 x ULN (within 14 days of signing the screening and leukapheresis consent) * Alanine aminotransferase (ALT) =\< 2.5 x ULN (within 14 days of signing the screening and leukapheresis consent) * Creatinine clearance of \>= 50 mL/min per the Cockcroft-Gault formula (within 14 days of signing the screening and leukapheresis consent) * Cardiac function (12 lead-electrocardiogram \[ECG\]) without acute abnormalities requiring investigation or intervention (within 14 days of signing the screening and leukapheresis consent) * Absolute neutrophil count \>= 750/uL (within 14 days of signing the screening and leukapheresis consent) * Hemoglobin (Hb) \>= 8 g/dl (within 14 days of signing the screening and leukapheresis consent) * Platelet count \>= 50,000/uL (within 14 days of signing the screening and leukapheresis consent) * Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) \> 40% (evaluation within 6 weeks of screening does not need to be repeated) (within 14 days of signing the screening and leukapheresis consent) * Oxygen (O2) saturation \> 92% not requiring oxygen supplementation (within 14 days of signing the screening and leukapheresis consent) * Seronegative for HIV qPCR, HCV\*, active HBV (Surface Antigen Negative), and syphilis (RPR) * If positive, Hepatitis C RNA quantitation must be performed. OR * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable. Meets other institutional and federal requirements for infectious disease titer requirements Note Infectious disease testing to be performed within 28 days prior to enrollment. * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days of signing the screening and leukapheresis consent) * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Exclusion Criteria: * Participant has not yet recovered from toxicities of prior therapy * Presence of systemic lymphoma * Participant with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the screening and leukapheresis consent * Participant with known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder * Active autoimmune disease requiring systemic immunosuppressive therapy * Needing dexamethasone more than 4mg/day (or equivalent) within 72 hours prior to leukapheresis or CAR T cell infusion * History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study * Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia * History of stroke or intracranial hemorrhage within 6 months prior to signing the screening and leukapheresis consent * History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent with no known active disease present for \>= 3 years, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin * Uncontrolled active infection * Active hepatitis B or hepatitis C infection: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded * Subjects who are hepatitis B core antibody positive (or have a known history of hepatitis B virus \[HBV\] infection) should be monitored quarterly with a quantitative PCR test for HBV deoxyribonucleic acid (DNA). HBV monitoring should last until 12 months after last dose of study drug. Any subject with a rising viral load (above lower limit of detection) should discontinue study drug and have antiviral therapy instituted and a consultation with a physician with expertise in managing hepatitis B. Subjects who are core antibody (Ab) positive at study enrollment are strongly recommended to start Entecavir before start and until completion of study treatment * Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded * Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded * Human immunodeficiency virus (HIV) infection * Active significant bacterial, fungal or viral (other than those listed) infections * Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

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