Can a quick radiation boost make CAR T-Cell therapy work better for lymphoma?
NCT ID NCT05621096
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether giving low-dose radiation before CAR T-cell therapy is feasible and safe for people with B-cell lymphoma that has come back or not responded to treatment. About 33 participants will receive two small doses of radiation, then standard CAR T-cell infusion. The main goal is to see if most patients can complete the full treatment plan, while also monitoring for serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-dose radiation and lisocabtagene maraleucel (CAR T-cell therapy)
- What this could lead to
- If successful, this approach could make CAR T-cell therapy more effective for patients with hard-to-treat B-cell lymphoma by using radiation to control the disease before infusion.
- What could go wrong
- This is a very early phase 1 trial with only 33 participants, so results may not apply to everyone. There are also 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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Sep 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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19 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Biopsy-proven relapsed or progressive diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, grade 3B follicular lymphoma, or DLBCL arising from indolent lymphoma meeting an FDA-approved (Food and Drug Administration-approved) indication for liso-cel infusion 2. Presence of disease on imaging including at least one disease site safe for radiation as determined by treating radiation oncologist 3. Willingness to participate in clinical trial and provide informed consent 4. Adequate organ function as assessed by standard institution protocols and United States (US) prescribing information label for comorbidities, heart, and lung function to undergo FDA-approved CAR T-cell therapy as determined by institution 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Age 19 years or older, there is no upper limit to the age Exclusion Criteria: 1. Subject is unsafe for radiation therapy as determined by investigator and/or radiation oncologist 2. Diagnosis is primary central nervous system (CNS) lymphoma (secondary CNS lymphoma with additional systemic site is allowed) 3. Requirement for concurrent high dose methotrexate 4. Secondary active malignancy that has not been in remission for at least 2 years. This excludes non-melanoma skin cancer, definitively treated stage 1 solid tumor with low risk or recurrence, and curatively treated localized prostate cancer. 5. Pregnant or nursing women 6. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as determined by investigator 7. Unwillingness to follow procedures required in the protocol 8. Inadequate organ or hematologic conditions that prohibit the use of lymphodepleting chemotherapy 9. Use of lymphoma-directed therapy within 14 days of T-cell pheresis
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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
-
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
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Other studies related to the condition(s) this trial covers.
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