Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL
NCT03019666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2022-11-04
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
- 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)
Sponsors & Collaborators
-
Masonic Cancer Center, University of Minnesota
lead OTHER
Principal Investigators
-
Veronika Bachanova, MD, PhD · University of Minnesota
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-10-18
- Primary Completion
- 2022-08-15
- Completion
- 2022-08-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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