Can statins and steroids tame CAR-T's brain risks?
NCT ID NCT04514029
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tests whether giving simvastatin (a cholesterol drug) and dexamethasone (a steroid) can safely prevent nerve-related side effects from axicabtagene ciloleucel (Axi-Cel) CAR-T therapy in adults with certain types of lymphoma. The study includes 37 participants and focuses on safety and feasibility, not yet on effectiveness. It is a small, single-center pilot study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Simvastatin and dexamethasone
- What this could lead to
- If successful, this could point toward a way to reduce serious nerve-related side effects from CAR-T therapy, making treatment safer.
- What could go wrong
- This is a very early, small pilot study with only 37 participants, so results may not apply widely. The drugs themselves can cause side effects.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
37 people
The number who actually took part.
- Started
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Aug 2020
- Expected to finish
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Dec 2026
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 to 80 years
- 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: * 18- 80 years of age * One of the following histologies: * Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or * Primary mediastinal B-cell lymphoma, or * High grade B-cell lymphoma, or * DLBCL arising from follicular lymphoma * Disease status: * Chemotherapy refractory disease after ≥2 lines of chemotherapy, or * Relapsed with no remission after ≥1 lines of salvage chemotherapy, or * Relapsed following autologous hematopoeitic stem cell transplantation (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post auto HCT, the subject must have no complete response, or relapse after the last line of therapy * Performance Status * ECOG performance status 0-2 * Adequate organ function defined as: * Renal function defined as: * eGFR ≥ 30 mL/min/1.73 m\^2 * Liver function defined as: * ALT and AST ≤ 5 times the ULN for age (unless due to disease) * Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN * Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA * Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment as outlined in axi-cel protocol. * Able to provide written voluntary consent (or LAR consent for adults with diminished capacity) prior to the performance of any research related tests or procedures * Availability of a certified practitioner to perform the lumbar punctures Exclusion Criteria: * Allergies, or intolerance to simvastatin or dexamethasone * Already receiving a statin drug for hypercholesterolemia and unwilling to change medication to 40 mg/day of simvastatin * Active uncontrolled CNS lymphoma. Patients with history of CNS lymphoma who have been adequately treated are eligible * Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). * Uncontrolled active hepatitis B or hepatitis C * Active HIV infection * Uncontrolled acute life threatening bacterial, viral or fungal infection * Unstable angina and/or myocardial infarction * Risk factors that preclude a safe lumbar puncture (high intracranial pressure, bleeding diathesis that cannot be reversed or corrected, need for uninterrupted anticoagulation, platelets \< 50K that cannot be corrected with transfusional support * Pregnant or breastfeeding as agents used in this study are Pregnancy Category C (dexamethasone) and X (simvastatin). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of study registration.
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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.
Contacts and locations
Locations
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Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
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