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

Refractory B-Cell Non-Hodgkin Lymphoma Clinical Trial

Official title: Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To establish the safety and recommended phase II dose of umbilical cord blood (CB)-derived natural killer (NK) cells preloaded with the bispecific antibody AFM13 (AFM13-NK), followed by intravenous anti-CD30/CD16A monoclonal antibody AFM13 (AFM13) in patients with refractory/relapsed CD30-positive lymphoid malignancies based on incidence of dose limiting toxicities (DLTs) per dose level. (Phase I) II. To assess the activity of umbilical cord blood (CB)-derived natural killer (NK) cells preloaded with the bispecific antibody AFM13 (AFM13- NK), followed by intravenous AFM13 in patients with refractory/relapsed CD30-positive lymphoid malignancies. based on overall response rate (ORR), complete response (CR) rate and partial response (PR) rate. (Phase II)

SECONDARY OBJECTIVES:

I. To evaluate the duration of response. II. To evaluate the event-free survival (EFS) rate. III. To evaluate the overall survival (OS) time. IV. To quantify the persistence of infused donor CB AFM13-NK cells in the recipient.

V. To conduct comprehensive immune reconstitution studies.

OUTLINE: This is a dose-escalation study of AFM13-NK.

Patients receive standard of care fludarabine intravenously (IV) over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21.

After completion of study treatment, patients are followed up at 28 days, 8 weeks, 100 and 180 days and then every 3-6 months for 2 years. ;

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Mycoses
• Mycosis Fungoides
• Recurrence
• Recurrent Anaplastic Large Cell Lymphoma
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Recurrent Classic Hodgkin Lymphoma
• Recurrent Mycosis Fungoides
• Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Refractory Anaplastic Large Cell Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma
• Refractory Classic Hodgkin Lymphoma
• Refractory Mycosis Fungoides
• Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified

• NCT number: NCT04074746
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 18, 2020
• Completion date: April 15, 2025