Recurrent Diffuse Large B-Cell LymphomaEarly Phase 1NCT05800405
Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma
A Early Phase 1 study testing Biospecimen Collection, Chimeric Antigen Receptor T-Cell Therapy and Computed Tomography in people with Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
- What is being tested?
- Biospecimen Collection, Chimeric Antigen Receptor T-Cell Therapy and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2023to 4 Jan 2027
- Phase
- Early Phase 1
- 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
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines.
- Age: >= 18 years.
- Eastern Cooperative Oncology Group (ECOG) =< 2 or Karnofsky Performance Status (KPS) >= 60.
- Histologically confirmed large B-cell lymphoma.
- Relapsed/refractory disease.
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- Planned to undergo commercial CAR T-cell infusion within 3 months of enrollment.
- 6 or fewer sites (treatable with a maximum of 3 isocenters) of FDG-PET avid disease, treatable with a a maximum of 3 isocenters.
- Measurable disease e.g., at least 1.5 cm on CT/MRI or by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
- Fully recovered from the acute toxic effects (except alopecia) to =< grade 1 to prior anti-cancer therapy.
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 30 days prior to day 1 of protocol therapy).
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Who cannot join
- Prior CD19-directed therapy.
- Radiation therapy within 21 days prior to day 1 of protocol therapy.
- Central nervous system (CNS) disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Active diarrhea.
- Clinically significant uncontrolled illness.
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- Active infection requiring antibiotics.
- Other active malignancy.
- Females only: Pregnant.
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
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
City of Hope Medical Center
Duarte, California, 91010
Savita V. Dandapani, 626-218-5334 ext. 82071, sdandapani@coh.org
Savita V. Dandapani
About this study
Official title: A Feasibility Study of Bridging Radiation to All Sites of FDG-Avid Disease for Commercial CAR T-Cell Infusion in Patients With Large B-Cell Lymphoma
This early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood (leukapheresis). Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While the outcomes from CAR T-cell therapy appear favorable, in the time between leukapheresis and CAR T-cell infusion many patients have symptomatic or life-threatening disease which often requires bridging therapy. Bridging therapy aims to slow disease progression and control symptoms during this critical period prior to CAR T-cell infusion. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells. Giving bridging radiation therapy to patients with relapsed or refractory LBCL prior to CAR T-cell infusion may improve treatment outcomes with minimal toxicity.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate if bridging radiation to all sites of F-fluorodeoxyglucose (FDG)-avid disease can be feasibly administered prior to commercial CAR T-cell infusion in patients with large B-cell lymphoma (LBCL).
SECONDARY OBJECTIVES:
- Assess the toxicities of bridging radiation in patients with LBCL. II. Assess overall response rate, complete response rate, progression-free survival, local control, distant control, and overall survival after bridging radiation and CAR T-cell infusion in patients with LBCL.
EXPLORATORY OBJECTIVES:
- Bank blood for future immune profiling or other correlatives. II. Explore the association between positron emission tomography (PET)/computed tomography (CT) radiomic features and clinical outcomes.
III. Collect PET/CT imaging data using the RefleXion X1 linear accelerator imaging system.
OUTLINE:
Patients undergo leukapheresis per standard of care, undergo external beam radiation therapy, and undergo CAR T-cell infusion per standard of care on study. Patients undergo PET/CT throughout the study and may undergo magnetic resonance imaging (MRI) during screening. Patients also undergo blood sample collection throughout the study.
- Being tested
- Biospecimen Collection, Chimeric Antigen Receptor T-Cell Therapy, Computed Tomography, External Beam Radiation Therapy, Leukapheresis
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Chimeric Antigen Receptor T-Cell TherapyBiological
Also called CAR T Infusion, CAR T Therapy, CAR T-cell Therapy, Chimeric Antigen Receptor T-cell Infusion
Receive CAR-T per standard of care
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy
Undergo radiation therapy
LeukapheresisProcedure or surgery
Also called Leukocytopheresis, Therapeutic Leukopheresis
Receive leukapheresis
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (leukapheresis, external beam radiation, CAR-T) | Experimental | Patients undergo leukapheresis per standard of care, undergo external beam radiation therapy, and undergo CAR T-cell infusion per standard of care on study. Patients undergo PET/CT throughout the study and may undergo MRI during screening. Patients also undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Biological: Chimeric Antigen Receptor T-Cell Therapy; Procedure: Computed Tomography; Radiation: External Beam Radiation Therapy; Procedure: Leukapheresis; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants completing planned radiation therapy
Will be assessed by the proportion of participants completing planned radiation therapy without any grade 3 or higher radiation-attributable (possibly, probably, or definitely) adverse events (AEs), along with its associated 95% Clopper Pearson exact binomial confidence interval (CI). All participants who start protocol radiation therapy are evaluable.
Measured: From the first fraction of radiation until approximately 1 month after infusion of chimeric antigen receptor (CAR) T-cell therapy
Secondary outcomes (7)
Incidence of AEs
Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 except in the case of cytokine release syndrome and neurotoxicity, which will be graded by American Society for Transplantation and Cellular Therapy Consensus Grading and not NCI CTCAE v5.0. All participants who receive any fraction of protocol radiation are evaluable.
Measured: Up to 1 year
Objective response rate
Will be defined as the proportion of participants that achieve a best response of either complete response (CR) or partial response after CAR T-cell infusion and prior to disease progression and/or start of other anti-lymphoma therapy, along with its associated 95% Clopper Pearson exact binomial CI. Only participants who receive CAR T-cell infusion post protocol radiation are evaluable.
Measured: Up to 1 year
Complete response rate
Will be defined as the proportion of participants that achieve a best response of CR after CAR T-cell infusion and prior to disease progression and/or start of other anti-lymphoma therapy, along with its associated 95% Clopper Pearson exact binomial CI. Only participants who receive CAR T-cell infusion post protocol radiation are evaluable.
Measured: Up to 1 year
Progression free survival
Will be assessed only in participants who receive CAR T-cell infusion post protocol radiation are evaluable for this endpoint. Will be estimated for patients who received radiation and CAR T-cells using the Kaplan Meier method along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Measured: Time from CAR T-cell infusion to time of disease relapse/progression or death due to any cause, whichever occurs first, assessed up to 1 year
Overall survival
Will be assessed only in participants who receive CAR T-cell infusion post protocol radiation are evaluable. Will be estimated for patients who received radiation and CAR T-cells using the Kaplan Meier method along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Measured: Time from CAR T-cell infusion to time of death due to any cause, assessed up to 1 year
Local control
Will be defined as the 80% isodose line. Only participants who receive CAR T-cell infusion post protocol radiation are evaluable. Will be analyzed by competing risk method where death without any progression will also be treated as a competing risk event.
Measured: Time from CAR T-cell infusion to time of disease relapse/progression within the radiation field, assessed up to 1 year
Distant control
Will be defined as the 80% isodose line. Only participants who receive CAR T-cell infusion post protocol radiation are evaluable. Will be analyzed by competing risk method where death without any progression will also be treated as a competing risk event.
Measured: Time from CAR T-cell infusion to time of disease relapse/progression outside the radiation field, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start20 Jul 2023
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Savita V Dandapani, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800405
- Sponsor's protocol ID
- 22141
- Other IDs
- NCI-2023-02190, 22141, P30CA033572
- Status last verified
- Feb 2026
- First submitted
- 24 Mar 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Bridging Radiation to All Sites of FDG-Avid Disease for Commercial CAR T-Cell Infusion in Patients With Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05800405
- Acronym / sponsor ID
- 22141
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 5 Apr 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 early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood (leukapheresis). Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While the outcomes from CAR T-cell therapy appear favorable, in the time between leukapheresis and CAR T-cell infusion many patients have symptomatic or life-threatening disease which often requires bridging therapy. Bridging therapy aims to slow disease progression and control symptoms during this critical period prior to CAR T-cell infusion. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells. Giving bridging radiation therapy to patients with relapsed or refractory LBCL prior to CAR T-cell infusion may improve treatment outcomes with minimal toxicity.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate if bridging radiation to all sites of F-fluorodeoxyglucose (FDG)-avid disease can be feasibly administered prior to commercial CAR T-cell infusion in patients with large B-cell lymphoma (LBCL).
SECONDARY OBJECTIVES:
- Assess the toxicities of bridging radiation in patients with LBCL. II. Assess overall response rate, complete response rate, progression-free survival, local control, distant control, and overall survival after bridging radiation and CAR T-cell infusion in patients with LBCL.
EXPLORATORY OBJECTIVES:
- Bank blood for future immune profiling or other correlatives. II. Explore the association between positron emission tomography (PET)/computed tomography (CT) radiomic features and clinical outcomes.
III. Collect PET/CT imaging data using the RefleXion X1 linear accelerator imaging system.
OUTLINE:
Patients undergo leukapheresis per standard of care, undergo external beam radiation therapy, and undergo CAR T-cell infusion per standard of care on study. Patients undergo PET/CT throughout the study and may undergo magnetic resonance imaging (MRI) during screening. Patients also undergo blood sample collection throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (leukapheresis, external beam radiation, CAR-T) | Experimental | Procedure: Biospecimen Collection, Biological: Chimeric Antigen Receptor T-Cell Therapy, Procedure: Computed Tomography, Radiation: External Beam Radiation Therapy, Procedure: Leukapheresis, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission TomographyPatients undergo leukapheresis per standard of care, undergo external beam radiation therapy, and undergo CAR T-cell infusion per standard of care on study. Patients undergo PET/CT throughout the study and may undergo MRI during screening. Patients also undergo blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Documented informed consent of the participant and/or legally authorized representative.
- Age: >= 18 years.
- Eastern Cooperative Oncology Group (ECOG) =< 2 or Karnofsky Performance Status (KPS) >= 60.
- Histologically confirmed large B-cell lymphoma.
- Relapsed/refractory disease.
Key exclusion criteria (11 listed)
- Prior CD19-directed therapy.
- Radiation therapy within 21 days prior to day 1 of protocol therapy.
- Central nervous system (CNS) disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Active diarrhea.
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (leukapheresis, external beam radiation, CAR-T) |
| Chimeric Antigen Receptor T-Cell TherapyAlso: CAR T Infusion, CAR T Therapy, CAR T-cell Therapy, Chimeric Antigen Receptor T-cell InfusionReceive CAR-T per standard of care | Biological | Treatment (leukapheresis, external beam radiation, CAR-T) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Treatment (leukapheresis, external beam radiation, CAR-T) |
| External Beam Radiation TherapyAlso: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam RadiotherapyUndergo radiation therapy | Radiation | Treatment (leukapheresis, external beam radiation, CAR-T) |
| LeukapheresisAlso: Leukocytopheresis, Therapeutic LeukopheresisReceive leukapheresis | Procedure or surgery | Treatment (leukapheresis, external beam radiation, CAR-T) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Treatment (leukapheresis, external beam radiation, CAR-T) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT | Procedure or surgery | Treatment (leukapheresis, external beam radiation, CAR-T) |
Primary outcome
Proportion of participants completing planned radiation therapy
Time frame: From the first fraction of radiation until approximately 1 month after infusion of chimeric antigen receptor (CAR) T-cell therapy
Will be assessed by the proportion of participants completing planned radiation therapy without any grade 3 or higher radiation-attributable (possibly, probably, or definitely) adverse events (AEs), along with its associated 95% Clopper Pearson exact binomial confidence interval (CI). All participants who start protocol radiation therapy are evaluable.
7 secondary outcomes
Incidence of AEs
Time frame: Up to 1 year
Objective response rate
Time frame: Up to 1 year
Complete response rate
Time frame: Up to 1 year
Progression free survival
Time frame: Time from CAR T-cell infusion to time of disease relapse/progression or death due to any cause, whichever occurs first, assessed up to 1 year
Overall survival
Time frame: Time from CAR T-cell infusion to time of death due to any cause, assessed up to 1 year
Local control
Time frame: Time from CAR T-cell infusion to time of disease relapse/progression within the radiation field, assessed up to 1 year
Distant control
Time frame: Time from CAR T-cell infusion to time of disease relapse/progression outside the radiation field, assessed up to 1 year
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 4 Feb 2026.
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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.
Savita V Dandapani principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biospecimen Collection, Chimeric Antigen Receptor T-Cell Therapy and Computed Tomography in people with Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by City of Hope Medical Center 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 11 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 4 Feb 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants completing planned radiation therapy (time frame: From the first fraction of radiation until approximately 1 month after infusion of chimeric antigen receptor (CAR) T-cell therapy). 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 4 Feb 2026.