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Can a quick radiation boost make CAR T-Cell therapy work better for lymphoma?

NCT ID NCT05621096

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 33 people

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

Started

Mar 2023

Expected to finish

Sep 2027

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

19 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: 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.