RecruitingPhase 2NCT06104592

Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL

Phase 2, Single-Arm Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to CD19 CAR-T Cell Therapy in High-Risk, Relapsed or Refractory Large B Cell Lymphoma in Patients With Bulky Disease

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

27 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

Large B-cell Lymphoma

Summary

This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving radiation to all visible lymphoma sites before CAR-T cell therapy (a type of immunotherapy) improves outcomes for patients with large B-cell lymphoma (LBCL) that has returned or is not responding to treatment. The radiation acts as a "bridge" to prepare the body before the CAR-T infusion. **You may be eligible if...** - You have been diagnosed with diffuse large B-cell lymphoma (DLBCL) - You are eligible and planned to receive CAR-T cell therapy (specifically axicabtagene ciloleucel) - You have at least one large tumor (5 cm or more) that can be targeted by radiation - Radiation to all visible disease sites is feasible - Your general health status is adequate (ECOG 0–2) - You do not have lymphoma in the brain **You may NOT be eligible if...** - There is evidence or suspicion of active central nervous system involvement - You are pregnant or breastfeeding - Your organ function is inadequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONComprehensive Ablative Bridging Irradiation (CABI)

Participants will receive radiation therapy to all pretreatment lesions that are able to be feasibly and safely treated.

BIOLOGICALChimeric Antigen Receptor T-Cell Therapy

Yascarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells. The reengineered T cells are infused back into the patient to attack the cancer.