Trials / Completed
CompletedNCT03019666
Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL
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 and Relapsed/Refractory CD20+ Non-Hodgkin Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Diffuse Large B Cell Lymphoma
- Mantle-Cell Lymphoma
- Follicular Lymphoma
- Indolent B Cell Lymphoma
- Primary Mediastinal Lymphoma
- Lymphoplasmacytic Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells | * Cyclophosphamide 40 mg/kg x 1 day on Day -5 * Fludarabine 25 mg/m\^2 x 3 days (Day -5, Day -4, day-3) |
Timeline
- Start date
- 2017-10-18
- Primary completion
- 2022-08-15
- Completion
- 2022-08-15
- First posted
- 2017-01-12
- Last updated
- 2022-11-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03019666. Inclusion in this directory is not an endorsement.