Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT04558853 |
Recruitment Status :
Active, not recruiting
First Posted : September 22, 2020
Last Update Posted : February 17, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: autologous NK cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Safety Study of CellProtect, an Autologous ex Vivo Expanded and Activated Natural Killer (NK) Cell Product, in Patients With Multiple Myeloma |
Actual Study Start Date : | January 1, 2014 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Autologous NK cells
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
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Drug: autologous NK cells
Autologous ex vivo expanded and activated NK cells |
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: From first dose of study treatment up until six months from last infusion. ]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.
- Changes on serum monoclonal immunoglobulin levels as a marker of efficacy [ Time Frame: From date of screening through study completion, up until six months from last infusion ]Changes in absolute and relative levels of laboratory parameters
- Changes on urine monoclonal immunoglobulin levels as a marker of efficacy [ Time Frame: From date of screening through study completion, up until six months from last infusion ]Changes in absolute and relative levels of laboratory parameters
- Changes on serum free light chain levels as a marker of efficacy [ Time Frame: From date of screening through study completion, up until six months from last infusion ]Changes in absolute and relative levels of laboratory parameters
- Effect of CellProtect on plasma cell fraction in bone marrow [ Time Frame: From date of screening up until one month from last infusion ]Changes in bone marrow clonal plasma cells
- Response assessment as defined by the International Myeloma Working Group uniform response criteria [ Time Frame: From date of screening up until six months from last infusion ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558853
Sweden | |
Karolinska University Hospital | |
Stockholm, Sweden, 141 57 |
Principal Investigator: | Hareth Nahi, M.D. | Karolinska University Hospital |
Responsible Party: | Hareth Nahi, Principal Investigator, Karolinska University Hospital |
ClinicalTrials.gov Identifier: | NCT04558853 |
Other Study ID Numbers: |
ACP-001 |
First Posted: | September 22, 2020 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
NK cells Consolidation |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |