Radiation after failed CAR t: tiny study halted early
NCT ID NCT04473937
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This pilot study looked at whether radiation therapy could help people with lymphoma that did not respond to CAR T cell therapy. Only 3 participants were enrolled before the study was terminated. The main goal was to check safety and side effects of adding radiation shortly after CAR T treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiotherapy
- What this could lead to
- If it works, this could offer a way to improve outcomes for lymphoma patients who don't respond to CAR T cell therapy.
- What could go wrong
- This was a very small pilot study (only 3 participants) that was terminated early, so we have very little data. The approach may not be effective or safe for most patients.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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3 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Jul 2023
- 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: * Patients must be able to undergo biopsy. Biopsy will be obtained for patients to exclude possibility of false negative residual FDG avidity on PET/CT that is not substantially increased relative to pre-CAR-T PET/CT. Exceptions are allowed for patients who have clearly progressive disease for whom delaying radiation therapy to obtain a biopsy may worsen outcome (such as cases of cord compression), and for patients for whom the risks of biopsy are high (such as patients with evidence for CNS involvement). * Biopsy-confirmed refractory disease within 30-90 days following commercial axicabtagene ciloleucel or tisagenlecleucel therapy for a hematologic malignancy (these include relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma). Of note, 'refractory' refers to patients who had early refractory disease after CAR-T cell therapy and not to patients who have received CAR-T for refractory disease, but had complete response to CAR-T cell therapy. * At least 1 measurable lesion according to the Lugano criteria1. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy * The following criteria pertain to pattern of progression: * Patients may have one refractory lesion without other residual or progressive disease as per PET/CT * Patients may have more than one refractory lesion, but with evidence for at least partial response of at least one other lesion as per PET/CT * Patients with more than one site of refractory disease without evidence for at least partial response of at least one other lesion are eligible if they are: * A. Symptomatic from a refractory lesion (such as cord compression or focal pain) or * B. Have disease that can locally affect the spinal canal or brain if left untreated. * Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia and prolonged cytopenias that are not expected to worsen during RT) if there is concern for overlap of anticipated radiation-related toxicity and toxicity from prior therapy due to where the RT field is located. * Age 18 or older * Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Any medical condition likely to interfere with assessment of safety or efficacy of RT * Patients with more than one site of disease without any evidence for response to CAR T cell therapy who are not focally symptomatic due to progressive disease or do not have disease that can locally affect the spinal canal or brain if left untreated * Women of child-bearing potential who are pregnant because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential. * In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
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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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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
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