Using low-dose radiation to improve CAR T-cell therapy for B-cell lymphoma
Feasibility of Low Dose Radiation as Bridging Therapy for Lisocabtagene Maraleucel in Relapsed B-Cell Non-Hodgkin Lymphoma
This study is testing if low-dose radiation can help improve CAR T-cell therapy for patients with aggressive B-cell lymphoma that hasn't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | CAR T, chemotherapy, radiation, methotrexate, chimeric antigen receptor |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT05621096 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and safety of administering low-dose radiation therapy as a bridging treatment for patients with relapsed and refractory aggressive B-cell lymphoma before they receive chimeric antigen receptor (CAR) T-cell therapy. The study focuses on patients whose cancer has not responded to previous treatments or has worsened. By targeting specific disease sites with radiation, the researchers hope to enhance the effectiveness of CAR T-cell therapy, which has shown promising results in this patient population. The findings from this pilot study could lead to a larger trial to further assess the efficacy of this combined approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with biopsy-proven relapsed or progressive B-cell lymphoma who are eligible for CAR T-cell therapy.
Not a fit: Patients who are deemed unsafe for radiation therapy or do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with relapsed B-cell lymphoma by enhancing the effectiveness of CAR T-cell therapy.
How similar studies have performed: While CAR T-cell therapy has shown success in treating B-cell lymphomas, the specific combination with low-dose radiation as a bridging therapy is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Biopsy-proven relapsed or progressive diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, grade 3B follicular lymphoma, or DLBCL arising from indolent lymphoma meeting an FDA-approved (Food and Drug Administration-approved) indication for liso-cel infusion 2. Presence of disease on imaging including at least one disease site safe for radiation as determined by treating radiation oncologist 3. Willingness to participate in clinical trial and provide informed consent 4. Adequate organ function as assessed by standard institution protocols and United States (US) prescribing information label for comorbidities, heart, and lung function to undergo FDA-approved CAR T-cell therapy as determined by institution 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Age 19 years or older, there is no upper limit to the age Exclusion Criteria: 1. Subject is unsafe for radiation therapy as determined by investigator and/or radiation oncologist 2. Diagnosis is primary central nervous system (CNS) lymphoma (secondary CNS lymphoma with additional systemic site is allowed) 3. Requirement for concurrent high dose methotrexate 4. Secondary active malignancy that has not been in remission for at least 2 years. This excludes non-melanoma skin cancer, definitively treated stage 1 solid tumor with low risk or recurrence, and curatively treated localized prostate cancer. 5. Pregnant or nursing women 6. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as determined by investigator 7. Unwillingness to follow procedures required in the protocol 8. Inadequate organ or hematologic conditions that prohibit the use of lymphodepleting chemotherapy 9. Use of lymphoma-directed therapy within 14 days of T-cell pheresis
Where this trial is running
Omaha, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Christopher R D'Angelo, MD — University of Nebraska
- Study coordinator: Maribeth A Hohenstein, RN
- Email: mahohens@unmc.edu
- Phone: 402-559-9053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.