Bridging radiation therapy before CAR T-cell infusion for 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

This study is testing whether giving radiation therapy before CAR T-cell treatment can help people with relapsed or hard-to-treat large B-cell lymphoma feel better and have better outcomes.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: City of Hope Medical Center (other)
• Drugs / interventions: CAR T, Radiation, chimeric antigen receptor
• Locations: 1 site (Duarte, California)
• Trial ID: NCT05800405 on ClinicalTrials.gov

What this trial studies

This early phase I clinical trial evaluates the feasibility of administering bridging radiation therapy to all sites of FDG-avid disease prior to CAR T-cell infusion in patients with relapsed or refractory large B-cell lymphoma. The study aims to assess the toxicities associated with this approach and measure various clinical outcomes such as overall response rate and progression-free survival. Patients will undergo leukapheresis, receive external beam radiation therapy, and then have CAR T-cell infusion, with imaging and blood sample collection throughout the study to monitor progress and outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed relapsed or refractory large B-cell lymphoma who are planned to undergo CAR T-cell infusion.

Not a fit: Patients with large B-cell lymphoma that is not FDG-PET avid or those with more than six sites of disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with difficult-to-treat large B-cell lymphoma.

How similar studies have performed: While CAR T-cell therapy has shown favorable outcomes, the specific combination with bridging radiation therapy is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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).

Where this trial is running

Duarte, California

• City of Hope Medical Center — Duarte, California, United States (RECRUITING)

Study contacts

• Principal investigator: Savita V Dandapani — City of Hope Medical Center

Conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma