🏛️ Verified NIH Record • Updated 2026-03-30

Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL (NCT06104592)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: H. Lee Moffitt Cancer Center and Research Institute

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (14 items).

Location: Moffitt Cancer Center — Tampa, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients who are currently receiving or who have received any other investigational study agent ≤4 weeks prior to screening visit are ineligible
  • Prior treatment with chimeric antigen receptor (CAR) T-cell therapy
  • Inability to safely deliver comprehensive radiation therapy to all sites of disease per treating radiation oncologists' discretion
  • Participants with clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from screening, New York Health Association III or IV heart failure, and circulatory collapse requiring vasopressor or inotropic support.
  • Participants with arrhythmias that are not stable on a medical management program within 2 weeks of screening are also excluded.
  • Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
  • Known positive Human immunodeficiency virus (HIV) status.
  • Participants with evidence of active and/or chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Participants with a history of hepatitis C virus (HCV) infection, HCV must have a negative nucleic acid test post-treatment or spontaneous clearance.
  • Participants who require the concurrent use of chronic systemic steroids or immunosuppressant medications. Steroids should not be given within 5 days prior to leukapheresis. Concomitant bridging steroids (Section 6.6) are allowed after leukapheresis.
  • Any condition that would, in the investigator's judgement, interfere with full participation in the study and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere with interpretation of study data.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Moffitt Cancer Center — Tampa, Florida

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗