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Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for Preventing CAR T-Cell Neurotoxicity

This study is testing if giving a combination of cytarabine, methotrexate, and hydrocortisone directly into the fluid around your spinal cord (intrathecal or IT) can prevent severe neurotoxicity (ICANS) in patients receiving CAR T-cell therapy. ICANS is a challenging side effect of CAR T-cell therapy that can cause neurological issues like headaches, confusion, or seizures. The study aims to see if this IT treatment can reduce the number of patients who experience severe ICANS. You may be able to join if you are 18 or older and are receiving Yescarta® or Tecartus® CAR T-cell therapy. The study will measure how many patients develop severe ICANS between 4 and 30 days after their CAR T-cell treatment.

Study design
This is an interventional study with a planned enrollment of 26 participants. It is not specified if it is a randomized or blinded study.
What's involved
You will receive cytarabine, methotrexate, and hydrocortisone IT via lumbar puncture on day 4 after CAR T-cell therapy. You will also have cerebrospinal fluid (CSF) samples collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 30 days after completing the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06895473

Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome

Recruiting
PHASE2Ages 18+InterventionalSupportive care
OHSU Knight Cancer Institute
~26 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCytarabineLumbar PunctureMethotrexateTherapeutic Hydrocortisone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of American Society for Transplantation and Cellular Therapy (ASTCT) ≥ grade 3 immune-effector cell associated neurotoxicity syndrome (ICANS)
Measured over From first dose of intrathecal (IT) chemotherapy (chimeric antigen receptor [CAR]-T day 4) to CAR-T day 30

Conditions

Hematopoietic and Lymphatic System Neoplasm

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • OHSU Knight Cancer Institute

    Portland, Oregonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stephen E Spurgeon · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Stephen E. Spurgeon
[email protected]
503-494-8950
Email the study team

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Eligibility criteria

Inclusion

Written informed consent. Participant or legally authorized representative (LAR) must provide written informed consent prior to any study-specific procedures or interventions
Age ≥ 18 years. All genders, races, and ethnic groups will be included
Must be receiving SOC Yescarta® or Tecartus® in the inpatient setting
Agree to adhere to institutional guidelines for contraception during the first 30 days post CAR-T
Rationale for eligibility criteria based on contraception and pregnancy (both participants and partners of a sperm-producing participant): It shall be known to all participants that the effects of CAR-T or IT chemotherapy on the developing human fetus are unknown. For this reason, persons of reproductive potential must agree to use adequate contraception. Should a participant or participant's sexual partner become pregnant or suspect a pregnancy while participating in this study, the individual should inform their treating physician immediately
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Platelet count \> 50,000/mm\^3 (μL)
Adequate coagulation tests including international normalized ratio (INR) \< 1.6 and fibrinogen \> 100

Exclusion

Active/concurrent diagnosis of any central nervous system (CNS) hematologic malignancy
History or presence of CNS disorder such as poorly controlled seizure disorder (seizure within the 12 months), transverse myelitis, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
Known history of hypersensitivity to IT chemotherapy
Subject has a contraindication to LP including:
Presence of a posterior fossa mass
Skin infection near puncture site
Uncorrected bleeding diathesis
Suspicion of increased intracranial pressure
Acute spinal cord trauma
Subject is receiving an antiplatelet and/or anticoagulant that cannot be held prior to LP according to best available evidence
Known bleeding disorders
Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgement, make the participant inappropriate for study participation or would put the participant at risk

What this trial measures

  • Incidence of American Society for Transplantation and Cellular Therapy (ASTCT) ≥ grade 3 immune-effector cell associated neurotoxicity syndrome (ICANS)From first dose of intrathecal (IT) chemotherapy (chimeric antigen receptor [CAR]-T day 4) to CAR-T day 30

    Will be reported using the efficacy set. Point estimate, along with exact two-sided 95% confidence interval will be reported.