RecruitingPhase 1Phase 2NCT06768905

IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL

IOMAB-ACT: A Phase Ib/II Multi-institutional Study of 131 I-Apamistamab Followed by CD19-Targeted CAR-T Cell Therapy for Patients With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)


Sponsor

University of Texas Southwestern Medical Center

Enrollment

30 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Summary

This study is being done to determine the safety, efficacy and tolerability of a single 50 mCi dose of 131I-Apamistamab given prior to FDA approved (commercially available) infusion in patients with Relapsed or refractory (R/R) non-Hodgkin lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new approach to preparing patients for CAR-T cell therapy in relapsed or treatment-resistant diffuse large B-cell lymphoma (DLBCL). Instead of standard lymphodepletion chemotherapy before CAR-T infusion, this study uses IOMAB-ACT — a targeted radioimmunotherapy drug — to clear space in the bone marrow for the CAR-T cells to grow. **You may be eligible if...** - You have been diagnosed with relapsed or refractory DLBCL (de novo, transformed from follicular lymphoma, or high-grade B-cell lymphoma) - You have received at least one prior chemoimmunotherapy regimen that included an anthracycline and a CD20-directed therapy (like rituximab) - You are considered eligible for standard-of-care CAR-T cell therapy by your treatment team - You meet standard CAR-T eligibility requirements regarding organ function and performance status **You may NOT be eligible if...** - Your lymphoma has not relapsed or is still responding to current treatment - You have not yet tried standard eligible therapies - Your organ function does not support CAR-T therapy - You have active uncontrolled infections or other serious conditions 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

DRUGIomab-B

single 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion.

DRUGCAR-T cell

CAR-T cell therapy


Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT06768905