NCT04512716

Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

Study Summary

This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.

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Interventions

131-I ApamistamabDRUG
Patients will receive 131-I apamistamab 5-7 days prior to a single infusion of 1x10\^6 19-28z CAR T-cells/kg for those in the B-ALL cohort, or 2x10\^6 19-28z CAR T-cells/kg, for those in the DLBCL. 131-I apamistamab may be administered inpatient or outpatient at the discretion and judgment of the treating investigators.
CAR T-cellBIOLOGICAL
19-28z CAR T-cells will be administered inpatient as a single infusion of 1x10\^6 19-28z CAR T-cells/kg, for those in the B-ALL cohort, or 2x10\^6 19-28z CAR T-cells/kg, for those in the DLBCL cohort. Patients will be observed inpatient for a minimum of 7 days (longer as clinically indicated and at the discretion of the treating physician).

Study Locations

FacilityCityStateCountry
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew JerseyUnited States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew JerseyUnited States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew JerseyUnited States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew YorkUnited States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew YorkUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew YorkUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026