Phase 2 Study of Radiation Before CAR T-Cell Therapy for Large B-Cell Lymphoma
This study is for people with high-risk relapsed or refractory (R/R) large B-cell lymphoma (LBCL) that has bulky disease (tumors 5 cm or larger). It's testing if giving Comprehensive Ablative Bridging Irradiation (CABI) – a type of radiation therapy – before Chimeric Antigen Receptor T-Cell Therapy (CAR T-cell therapy) is safe and effective. CAR T-cell therapy, specifically Yescarta, uses your own T-cells, which are reprogrammed to fight cancer. The study aims to enroll 27 participants and will measure how long people live without their cancer growing or spreading (Progression Free Survival) at 12 months. To join, you must have a confirmed diagnosis of DLBCL and plan to receive treatment at Moffitt Cancer Center. The current recruitment status is unclear.
- Study design
- This is a Phase 2, single-arm, open-label study, meaning all participants receive the same treatment, and both you and your doctors will know what treatment you are getting. The study plans to include 27 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants to measure Progression Free Survival at 12 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06104592
Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL
Recruiting
PHASE2Ages 18+InterventionalTreatmentH. Lee Moffitt Cancer Center and Research InstituteInvestigator-initiated
~27 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Comprehensive Ablative Bridging Irradiation (CABI)Chimeric Antigen Receptor T-Cell Therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over at 12 months
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Michael Jain, MD, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients with a histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) who plan to receive treatment at the Moffitt Cancer Center will be eligible.
Must have ability to comprehend and the willingness to sign written informed consent for study participation.
Eligible to receive CAR T-cell therapy (axicabtagene ciloleucel) for LBCL and histological variants approved by the standard of care label
ECOG performance status 0 to 2.
At least one high-risk lesion, defined as measuring ≥ 5 cm, that is targetable for radiotherapy per investigator assessment.
Ability to undergo comprehensive bridging radiation, defined as radiation to all visible sites of disease.
No evidence or suspicion of active central nervous system (CNS) involvement of lymphoma
Adequate bone marrow and organ function as defined in protocol.
Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow up and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants in their understanding confirmed.
Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at time of radiation treatment planning, per standard of care and departmental standard operating procedure. Patients must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
Women of non-childbearing potential (i.e., surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥12 months of amenorrhea) are eligible.
Exclusion
Patients who are currently receiving or who have received any other investigational study agent ≤4 weeks prior to screening visit are ineligible
Prior treatment with chimeric antigen receptor (CAR) T-cell therapy
Inability to safely deliver comprehensive radiation therapy to all sites of disease per treating radiation oncologists' discretion
Participants with clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from screening, New York Health Association III or IV heart failure, and circulatory collapse requiring vasopressor or inotropic support.
Participants with arrhythmias that are not stable on a medical management program within 2 weeks of screening are also excluded.
Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
Known positive Human immunodeficiency virus (HIV) status.
Participants with evidence of active and/or chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy, if indicated.
Participants with a history of hepatitis C virus (HCV) infection, HCV must have a negative nucleic acid test post-treatment or spontaneous clearance.
Participants who require the concurrent use of chronic systemic steroids or immunosuppressant medications. Steroids should not be given within 5 days prior to leukapheresis. Concomitant bridging steroids (Section 6.6) are allowed after leukapheresis.
Any condition that would, in the investigator's judgement, interfere with full participation in the study and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere with interpretation of study data.
In the investigator's 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 including ability to safely undergo radiation treatment planning and delivery.
Women of childbearing potential who are pregnant or breastfeeding. Females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential.
What this trial measures
- Progression Free Survival (PFS)at 12 months
PFS will be measured by date of CAR T-cell infusion until first occurrence of in-field, local, or distant progression, or death. If none of these events occur, patients will be censored on date of last contact.