Large B-cell LymphomaPhase 2NCT06104592
Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL
A Phase 2 study testing Comprehensive Ablative Bridging Irradiation (CABI) and Chimeric Antigen Receptor T-Cell Therapy in people with Large B-cell Lymphoma and Relapsed Non-Hodgkin Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-cell Lymphoma, Relapsed Non-Hodgkin Lymphoma
- What is being tested?
- Comprehensive Ablative Bridging Irradiation (CABI) and Chimeric Antigen Receptor T-Cell Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- No evidence or suspicion of active central nervous system (CNS) involvement of lymphoma
- Adequate bone marrow and organ function as defined in protocol.
- The effects of therapeutic agents used in this trial on developing human fetus are unknown, and because of this, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as outlined in criteria below:
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Michael Jain, MD, PhD
Nicholas Figura, MD
About this study
Official title: Phase 2, Single-Arm Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to CD19 CAR-T Cell Therapy in High-Risk, Relapsed or Refractory Large B Cell Lymphoma in Patients With Bulky Disease
This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.
- Being tested
- Comprehensive Ablative Bridging Irradiation (CABI), Chimeric Antigen Receptor T-Cell Therapy
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Ablative Bridging Irradiation (CABI)Radiation
Participants will receive radiation therapy to all pretreatment lesions that are able to be feasibly and safely treated.
Chimeric Antigen Receptor T-Cell TherapyBiological
Also called Axi-Cel, Yascarta
Yascarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells. The reengineered T cells are infused back into the patient to attack the cancer.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy and CAR T-Cell Infusion | Experimental | Following T-cell apheresis for CD19 CAR T-cell therapy, eligible enrolled study participants patients will undergo Comprehensive Ablative Bridging Irradiation (CABI) to all pretreatments lesions that are able to be feasibly and safely treated by the treating radiation oncologist. Upon completion of bridging radiotherapy, patients will undergo lymphodepleting chemotherapy period (Days -5, -4, -3) followed by axi-cel infusion (Day 0). Receives: Radiation: Comprehensive Ablative Bridging Irradiation (CABI); Biological: Chimeric Antigen Receptor T-Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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.
Measured: at 12 months
Secondary outcomes (6)
Rate of local relapse (i.e., relapse of lymphoma at a body site that received bridging radiation therapy)
Rate of local relapse determined by evidence of disease at a body site that received bridging radiation therapy.
Measured: up to 12 months
Rate of distant relapse (i.e., relapse of lymphoma at a body site that did not receive bridging radiation therapy)
Rate of distant relapse determined by evidence of disease at a body site that did not receive bridging radiation therapy.
Measured: up to 12 months
Number of serious adverse events attributed to bridging radiotherapy
Number of serious adverse events that can be attributed to bridging radiotherapy
Measured: Up to 12 months
Number of serious adverse events attributed to CAR T-cell infusion
Number of serious adverse events that can be attributed to CAR T-cell infusion
Measured: Up to 12 months
Number of participants experiencing severe cytokine release syndrome (CRS)
Number of participants experiencing severe CRS (grade 3 or higher by ASTCT criteria) in the first 30 days after CAR T-cell infusion.
Measured: at 30 days after CAR T infusion
Number of participants experiencing severe immune cell associated neurotoxicity syndrome (ICANS)
Number of participants experiencing severe ICANS (grade 3 or higher by ASTCT criteria) in the first 30 days after CAR T-cell infusion.
Measured: at 30 days after CAR T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start8 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kite, A Gilead Company
- Responsible party
- Sponsor
- Investigators
- Michael Jain, MD, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104592
- Sponsor's protocol ID
- MCC-22113
- Status last verified
- Mar 2026
- First submitted
- 23 Oct 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Single-Arm Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to CD19 CAR-T Cell Therapy in High-Risk, Relapsed or Refractory Large B Cell Lymphoma in Patients With Bulky Disease
- ClinicalTrials.gov ID
- NCT06104592
- Acronym / sponsor ID
- MCC-22113
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Kite, A Gilead Company
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy and CAR T-Cell Infusion | Experimental | Radiation: Comprehensive Ablative Bridging Irradiation (CABI), Biological: Chimeric Antigen Receptor T-Cell TherapyFollowing T-cell apheresis for CD19 CAR T-cell therapy, eligible enrolled study participants patients will undergo Comprehensive Ablative Bridging Irradiation (CABI) to all pretreatments lesions that are able to be feasibly and safely treated by the treating radiation oncologist. Upon completion of bridging radiotherapy, patients will undergo lymphodepleting chemotherapy period (Days -5, -4, -3) followed by axi-cel infusion (Day 0). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Ablative Bridging Irradiation (CABI)Participants will receive radiation therapy to all pretreatment lesions that are able to be feasibly and safely treated. | Radiation | Radiation Therapy and CAR T-Cell Infusion |
| Chimeric Antigen Receptor T-Cell TherapyAlso: Axi-Cel, YascartaYascarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells. The reengineered T cells are infused back into the patient to attack the cancer. | Biological | Radiation Therapy and CAR T-Cell Infusion |
Primary outcome
Progression Free Survival (PFS)
Time frame: 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.
6 secondary outcomes
Rate of local relapse (i.e., relapse of lymphoma at a body site that received bridging radiation therapy)
Time frame: up to 12 months
Rate of distant relapse (i.e., relapse of lymphoma at a body site that did not receive bridging radiation therapy)
Time frame: up to 12 months
Number of serious adverse events attributed to bridging radiotherapy
Time frame: Up to 12 months
Number of serious adverse events attributed to CAR T-cell infusion
Time frame: Up to 12 months
Number of participants experiencing severe cytokine release syndrome (CRS)
Time frame: at 30 days after CAR T infusion
Number of participants experiencing severe immune cell associated neurotoxicity syndrome (ICANS)
Time frame: at 30 days after CAR T infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Large B-cell Lymphoma
Active, not recruitingPhase 1/2
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
Not yet recruitingPhase 1
A Multicenter, Phase I Study to Evaluate the Feasibility and Safety of Autologous Cytokine-Induced Killer Cells (CIK_D332) in Combination With Tafasitamab and Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma (DLBCL)
RecruitingPhase 1/2
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
RecruitingPhase 2
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
Diffuse Large B-Cell Lymphoma
RecruitingPhase 2
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Large B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Jain, MD, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comprehensive Ablative Bridging Irradiation (CABI) and Chimeric Antigen Receptor T-Cell Therapy in people with Large B-cell Lymphoma and Relapsed Non-Hodgkin Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruthie Chae (813-745-3425, ICETtrials@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.