Spinal chemotherapy may stop brain damage from cancer treatment
NCT ID NCT06895473
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether injecting chemotherapy drugs (cytarabine, methotrexate, and hydrocortisone) into the spinal fluid can prevent severe brain side effects in people receiving CAR T-cell therapy for blood cancers. About 20-70% of CAR T patients develop neurotoxicity, which can cause confusion, seizures, or brain swelling. The study will enroll 26 adults and track how many develop serious brain symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cytarabine, methotrexate, and hydrocortisone injected into the spinal fluid
- What this could lead to
- If it works, this could make CAR T-cell therapy safer by preventing serious brain side effects, allowing more patients to benefit from this cancer treatment.
- What could go wrong
- This is a small, early-phase trial with only 26 participants, so results may not apply to everyone. The spinal injections themselves carry risks like headache 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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 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 Criteria: * 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
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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OHSU Knight Cancer Institute
RECRUITINGPortland, Oregon, 97239, United States
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