drugset / Trial / 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
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-02-02
- Primary completion
- 2027-01
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 19-28z CAR T-cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | 19-28z CAR T-cells | Cell therapy | 2e+06 cells/kg | — |
| Subject | IODINE I 131 APAMISTAMAB | Monoclonal antibody | 1850 mbq | — |
| Subject | IODINE I 131 APAMISTAMAB | Monoclonal antibody | 2775 mbq | — |