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Cell Therapy
Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells for Non-Hodgkin's Lymphoma
Phase 1
Waitlist Available
Led By Veronika Bachanova, MD, PhD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post infusion
Awards & highlights
Study Summary
This trial is testing a new therapy for cancer using expanded natural killer cells. The goal is to find the maximum tolerated dose while maintaining safety.
Eligible Conditions
- Mediastinal Lymphoma
- Non-Hodgkin's Lymphoma
- Multiple Myeloma
- B-Cell Non-Hodgkin Lymphoma
- Lymphoplasmacytic Lymphoma
- Follicular Lymphoma
- Mantle Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of Grade III or IV acute graft-versus-host disease (aGVHD)
Occurrence of any grade 4 or greater suspected adverse reaction
Secondary outcome measures
Number of patients alive without progression
Occurrence of disease response
Occurrence of treatment related mortality (TRM)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Non-Hodgkin LymphomaExperimental Treatment1 Intervention
After a lymphodepleting preparative regimen of cyclophosphamide and fludarabine, patients receive expanded NAM-NK cells followed by a short course of interleukin-2 (IL-2) to facilitate natural killer cell survival and expansion in vivo. Monoclonal antibodies and rituximab for Non-Hodgkin Lymphoma patients, will be administered prior to and after the natural killer cell infusion(s) to facilitate tumor targeting and antibody dependent cellular cytotoxicity (ADCC).
Group II: Multiple MyelomaExperimental Treatment1 Intervention
After a lymphodepleting preparative regimen of cyclophosphamide and fludarabine, patients receive expanded NAM-NK cells followed by a short course of interleukin-2 (IL-2) to facilitate natural killer cell survival and expansion in vivo. Monoclonal antibodies and elotuzumab for Multiple Myeloma patients, will be administered prior to and after the natural killer cell infusion(s) to facilitate tumor targeting and antibody dependent cellular cytotoxicity (ADCC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natural Killer Cell
Not yet FDA approved
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,586 Total Patients Enrolled
Veronika Bachanova, MD, PhDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
162 Total Patients Enrolled
Frequently Asked Questions
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