Back to resultsClinical Study of Autologous Natural Killer Cells in Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
autologous NK cells
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring NK cells, Consolidation
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent
- Above 18 years of age
- MM diagnosis (stage I-III according to the International Staging System)
- Eligible for, and willing to undergo, high dose chemotherapy and ASCT
- Measurable monoclonal immunoglobulins
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy of at least three months
Exclusion Criteria:
- Non-secretory MM
- Malignancy, other than MM, treated with chemotherapy or radiation within the past six months
- Blood donation or other significant blood loss within three months from screening
- Any physical condition or laboratory results that contraindicate a blood donation to be performed within four weeks from screening
- Any physical condition or laboratory results that require the chemotherapy to start before there is available slot for blood donation
- Known or suspected allergic reactions to any ingredient of the IP
- Diagnosis or indication of any active autoimmune disease, such as Rheumatoid Arthritis, Inflammatory Bowel Disease, Systemic Lupus Erythematosis or Multiple Sclerosis
- Uncontrolled or severe cardiovascular disease, such as myocardial infarction within six months from screening, heart failure (class III or IV according to New York Heart Association), uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis
- Poorly controlled hypertension
- Poorly controlled Diabetes Mellitus, type I or II
- Diagnosis or indication of any clinically relevant renal disease
- Diagnosis or indication of any clinically relevant hepatic disease
- Ongoing infection that is considered chronic
- Known or suspected drug or alcohol abuse, within 12 months from screening
- Pregnant, trying to become pregnant, or nursing
- Lack of, or unreliable contraceptive method, as judged by the Investigator
- Medical history or any abnormal physical finding that is clinically relevant and could interfere with the safety or objectives of the study, as judged by the Investigator
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous NK cells
Arm Description
The investigation product is a cell suspension based on ex vivo expanded NK cells from patients with MM. The treatment is strictly autologous. The IP is given as three infusions with escalating doses. Mode of administration Intravenous infusions. Dose levels First infusion; 5x10^6 cells/kg body weight Second infusion; 50x10^6 cells/kg body weight Third infusion; 100x10^6 cells/kg body weight
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Assessment of treatment-emergent adverse events/serious adverse events (TEAEs/SEAS)(including IARS). TEAEs are defined as AEs that develop, worsen (according to the Investigators opinion), or bedome serious during the treatment period.
Secondary Outcome Measures
Changes on serum monoclonal immunoglobulin levels as a marker of efficacy
Changes in absolute and relative levels of laboratory parameters
Changes on urine monoclonal immunoglobulin levels as a marker of efficacy
Changes in absolute and relative levels of laboratory parameters
Changes on serum free light chain levels as a marker of efficacy
Changes in absolute and relative levels of laboratory parameters
Effect of CellProtect on plasma cell fraction in bone marrow
Changes in bone marrow clonal plasma cells
Response assessment as defined by the International Myeloma Working Group uniform response criteria
Evaluation of response criteria, i.e. minimal response, partial response, very good partial response and complete response as assessed by International Myeloma Working Group uniform response criteria
Full Information
NCT ID
NCT04558853
First Posted
September 10, 2020
Last Updated
February 16, 2021
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04558853
Brief Title
Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma
Official Title
A Safety Study of CellProtect, an Autologous ex Vivo Expanded and Activated Natural Killer (NK) Cell Product, in Patients With Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Multiple Myeloma (MM) is a lethal disease and at present no available treatment method seems to prevent the disease from progressing or relapsing in the long term. NK cells have a relatively high cytotoxic capacity and an anti tumour effect, suggesting a potential as a treatment of MM.This is a phase I, first-in-human, therapeutic exploratory study, where no benefits for the patients can be guaranteed. However, the theoretical implication is that the infused cells may have a positive antitumour effect for the participating individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
NK cells, Consolidation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous NK cells
Arm Type
Experimental
Arm Description
The investigation product is a cell suspension based on ex vivo expanded NK cells from patients with MM. The treatment is strictly autologous. The IP is given as three infusions with escalating doses.
Mode of administration Intravenous infusions. Dose levels
First infusion; 5x10^6 cells/kg body weight
Second infusion; 50x10^6 cells/kg body weight
Third infusion; 100x10^6 cells/kg body weight
Intervention Type
Drug
Intervention Name(s)
autologous NK cells
Intervention Description
Autologous ex vivo expanded and activated NK cells
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Assessment of treatment-emergent adverse events/serious adverse events (TEAEs/SEAS)(including IARS). TEAEs are defined as AEs that develop, worsen (according to the Investigators opinion), or bedome serious during the treatment period.
Time Frame
From first dose of study treatment up until six months from last infusion.
Secondary Outcome Measure Information:
Title
Changes on serum monoclonal immunoglobulin levels as a marker of efficacy
Description
Changes in absolute and relative levels of laboratory parameters
Time Frame
From date of screening through study completion, up until six months from last infusion
Title
Changes on urine monoclonal immunoglobulin levels as a marker of efficacy
Description
Changes in absolute and relative levels of laboratory parameters
Time Frame
From date of screening through study completion, up until six months from last infusion
Title
Changes on serum free light chain levels as a marker of efficacy
Description
Changes in absolute and relative levels of laboratory parameters
Time Frame
From date of screening through study completion, up until six months from last infusion
Title
Effect of CellProtect on plasma cell fraction in bone marrow
Description
Changes in bone marrow clonal plasma cells
Time Frame
From date of screening up until one month from last infusion
Title
Response assessment as defined by the International Myeloma Working Group uniform response criteria
Description
Evaluation of response criteria, i.e. minimal response, partial response, very good partial response and complete response as assessed by International Myeloma Working Group uniform response criteria
Time Frame
From date of screening up until six months from last infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent
Above 18 years of age
MM diagnosis (stage I-III according to the International Staging System)
Eligible for, and willing to undergo, high dose chemotherapy and ASCT
Measurable monoclonal immunoglobulins
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy of at least three months
Exclusion Criteria:
Non-secretory MM
Malignancy, other than MM, treated with chemotherapy or radiation within the past six months
Blood donation or other significant blood loss within three months from screening
Any physical condition or laboratory results that contraindicate a blood donation to be performed within four weeks from screening
Any physical condition or laboratory results that require the chemotherapy to start before there is available slot for blood donation
Known or suspected allergic reactions to any ingredient of the IP
Diagnosis or indication of any active autoimmune disease, such as Rheumatoid Arthritis, Inflammatory Bowel Disease, Systemic Lupus Erythematosis or Multiple Sclerosis
Uncontrolled or severe cardiovascular disease, such as myocardial infarction within six months from screening, heart failure (class III or IV according to New York Heart Association), uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis
Poorly controlled hypertension
Poorly controlled Diabetes Mellitus, type I or II
Diagnosis or indication of any clinically relevant renal disease
Diagnosis or indication of any clinically relevant hepatic disease
Ongoing infection that is considered chronic
Known or suspected drug or alcohol abuse, within 12 months from screening
Pregnant, trying to become pregnant, or nursing
Lack of, or unreliable contraceptive method, as judged by the Investigator
Medical history or any abnormal physical finding that is clinically relevant and could interfere with the safety or objectives of the study, as judged by the Investigator
Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hareth Nahi, M.D.
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 57
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma
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