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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• B-ALL
• DLBCL
• B ALL
• Dlbcl-Ci
• DLBCL Unclassifiable
• DLBCL, Nos Genetic Subtypes
• DLBCL Activated B-Cell Type
• DLBCL Germinal Center B-Cell Type
• Diffuse Large B-cell Lymphoma
• HGBL
• HGBL, Nos

Interventions

Type	Name	Description
DRUG	131-I Apamistamab	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.
BIOLOGICAL	CAR T-cell	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).

Timeline

• Start date: 2021-02-02
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2020-08-13
• Last updated: 2026-02-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study