NCT04634435

Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients

A Phase 1 Study of Autologous Memory-like Natural Killer (NK) Cell Immunotherapy With BHV-1100 and IVIG Followed by Low Dose IL-2 as Early Post-Autologous Transplant Consolidation in Minimal Residual Disease Positive, Multiple Myeloma (MM) Patients in First or Second Remission

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Biohaven Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label single center Phase 1a/1b study with the primary objective of establishing the safety and exploring the efficacy of infusing the ex vivo combination product of BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2 in the peri-transplant setting in MM patients with minimal residual disease (MRD+) in first or second remission.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2	Single dose infusion of BHV-1100 plus CIML NK Cells plus IVIG, followed by low dose IL-2

Timeline

• Start date: 2021-10-21
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2020-11-18
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study