NCT05800405 Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma
| NCT ID | NCT05800405 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | City of Hope Medical Center |
| Condition | Recurrent Diffuse Large B-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2023-07-20 |
| Primary Completion | 2027-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2023-07-20 with a primary completion date of 2027-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
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).
Contact & Investigator
Savita V Dandapani
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT05800405 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recurrent Diffuse Large B-Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05800405 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05800405 currently recruiting?
Yes, NCT05800405 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.
Where is the NCT05800405 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT05800405 clinical trial?
NCT05800405 is sponsored by City of Hope Medical Center. The principal investigator is Savita V Dandapani at City of Hope Medical Center. The trial plans to enroll 9 participants.