New combo attack: CAR T-Cells plus radiation takes on tough lymphoma
NCT ID NCT06043323
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This phase 2 trial is testing whether combining a CAR T-cell therapy (axicabtagene ciloleucel) with radiation therapy is safe for people with follicular lymphoma that has returned or not responded to at least two prior treatments. About 20 adults will receive the treatment, and researchers will monitor side effects closely. The goal is to see if this combination can be a new option for hard-to-treat cases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- axicabtagene ciloleucel (CAR T-cell therapy)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with follicular lymphoma that has stopped responding to standard therapies.
- What could go wrong
- This is a small, early-phase trial (20 people) focused on safety, not yet proven to work. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and neurological problems.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Sep 2028
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: Eligible subjects will be considered for inclusion if they meet all of the following criteria: * Men and women 18 years of age or older * Histologically proven FL (Grade 1-3A) on most recent biopsy, history of transformed follicular lymphoma permitted at clinician discretion) * Patients with follicular lymphoma must have disease that has relapsed or is refractory to 2 or more prior lines of systemic therapy * (ECOG) performance status of 0-2 * Medically appropriate for CAR-T cell therapy: adequate organ function CrCL \>/= 45 mL/min/m2, hemoglobin level ≥ 8 g/dl, serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 x ULN if documented liver involvement, baseline oxygen saturation levels (SpO2) ≥92% on room air * Have at least 1 measurable lesion on imaging, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) and ≥1 cm on CT, MRI, or clinical exam. * Prior radiation therapy is permitted provided normal tissue tolerance is not exceeded * Female of child-bearing potential (FOCBP, defined below) must have a negative pregnancy test within 1 week of simulation for RT * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of other (non B-cell lymphoma) invasive malignancy requiring active therapy (systemic therapy, radiation, or surgery) within the past 3 years, excluding non-melanomatous skin cancer * Women of childbearing potential who are pregnant * Women who are breastfeeding and unwilling to discontinue prior to lymphodepleting chemotherapy and for 12 months following lymphodepleting chemotherapy and CAR-T cell infusion * Urgent need for bridging chemotherapy or rituximab between apheresis and CAR T cell product infusion (steroids permitted) * Additional RT would exceed standard organ at risk constraints * History of severe, immediate hypersensitivity reaction attributed to aminoglycosides * Uncontrolled fungal, bacterial, or viral infection requiring intravenous antimicrobials for management. Urinary tract infection and uncomplicated bacterial pharyngitis is permitted if responding to active treatment. Recent COVID19 infection is permitted if patient is deemed medically stable for CAR-T cell therapy.
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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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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- New antibody tested against aggressive blood cancer
- Can a new drug delay the need for lymphoma treatment?
- Can a single injection reprogram immune cells to fight cancer?
- Can a new immune cell therapy outsmart resistant blood cancers?
- Can a Triple-Drug combo wipe out Slow-Growing lymphomas?