NCT05800405RecruitingEarly phase 1
Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma
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
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 24 Mar 2023
- Start date
- 20 Jul 2023
- Primary completion date
- 4 Jan 2027
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05800405
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 9
- From 20 Jul 2023 to the primary completion date, 4 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CD19-directed therapy.
- Radiation therapy within 21 days prior to day 1 of protocol therapy.
Other illness
- Central nervous system (CNS) disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Clinically significant uncontrolled illness.
- Active infection requiring antibiotics.
- Other active malignancy.
- 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.
Other
- Active diarrhea.
- Females only: Pregnant.
- 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).
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.