Clinical Trial: Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase I Trial Testing NAM Expanded Haploidentical or Mismatched Related Donor Natural Killer (NK) Cells Followed by a Short Course of IL-2 for the Treatment of Relapsed/Refractory Multiple Myeloma a
Brief Summary: This is a phase I trial with pilot expansion of HLA-haploidentical or HLA-mismatched related donor nicotinamide expanded-natural killer (NAM-NK) cell based therapy for patients with relapsed or refractory multiple myeloma (MM) or relapsed/refractory CD20-positive non-Hodgkin lymphoma (NHL). The primary endpoint of the study is to determine the maximum tolerated dose (MTD) of NAM-NK cells while maintaining safety.
Detailed Summary:
Sponsor: Masonic Cancer Center, University of Minnesota
Current Primary Outcome:
- Occurrence of any grade 4 or greater suspected adverse reaction [ Time Frame: 24 hours post infusion ]
- Occurrence of Grade III or IV acute graft-versus-host disease (aGVHD) [ Time Frame: 28 days post infusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Occurrence of treatment related mortality (TRM) [ Time Frame: 2 months post infusion ]
- Occurrence of disease response [ Time Frame: 28 days post infusion ]
- Number of patients alive without progression [ Time Frame: 1 year post infusion ]
Original Secondary Outcome: Same as current
Information By: Masonic Cancer Center, University of Minnesota
Dates:
Date Received: January 11, 2017
Date Started: March 2017
Date Completion: March 2019
Last Updated: January 13, 2017
Last Verified: January 2017
