drugset / Trial / NCT04074746

Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas

NCT04074746

Phase 1/2 Completed 45 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer \[NK\] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30 positive Hodgkin lymphoma or non-Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as AFM13, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving AFM13 loaded with NK cells followed by AFM13 alone may kill more cancer cells and decrease cancer growth in patients with CD30 positive AFM13-NK Hodgkin and Non-Hodgkin lymphomas.

Timeline

Start
2020-07-18
Primary completion
2025-09-22
Completion
2025-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject ACIMTAMIG Protein / enzyme biologic Intravenous
Subject AFM13-NK Cell therapy 1e+06 cells/kg Intravenous
Subject AFM13-NK Cell therapy 1e+07 cells/kg Intravenous
Subject AFM13-NK Cell therapy 1e+08 cells/kg Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous