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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

NCT04512716 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-02-17

No results posted yet for this 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.

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

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).

Sponsors & Collaborators

Principal Investigators

  • Mark B Geyer, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512716 on ClinicalTrials.gov