NCT06768905

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label single-cohort multi-institutional study of 131I-Apamistamab followed by CAR-T cell therapy for patients with (R/R) DLBCL. Patients will receive a 50 mCi single planned 131I-Apamistamab dose prior to CAR-T cell infusion for lymphodepleting conditioning. There will be a 6-patient safety run-in to assess safety.

Conditions

• Non Hodgkin Lymphoma
• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Iomab-B	single 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion.
DRUG	CAR-T cell	CAR-T cell therapy

Timeline

• Start date: 2025-04-25
• Primary completion: 2029-05-01
• Completion: 2030-05-01
• First posted: 2025-01-10
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study