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Trial record 2 of 2 for:    CellProtect

Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558853
Recruitment Status : Active, not recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Hareth Nahi, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: autologous NK cells Phase 1

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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, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

  • First infusion; 5x10^6 cells/kg body weight
  • Second infusion; 50x10^6 cells/kg body weight
  • Third infusion; 100x10^6 cells/kg body weight
Drug: autologous NK cells
Autologous ex vivo expanded and activated NK cells




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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
Criteria

Inclusion Criteria:

  1. Signed Informed Consent
  2. Above 18 years of age
  3. MM diagnosis (stage I-III according to the International Staging System)
  4. Eligible for, and willing to undergo, high dose chemotherapy and ASCT
  5. Measurable monoclonal immunoglobulins
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  7. Life expectancy of at least three months

Exclusion Criteria:

  1. Non-secretory MM
  2. Malignancy, other than MM, treated with chemotherapy or radiation within the past six months
  3. Blood donation or other significant blood loss within three months from screening
  4. Any physical condition or laboratory results that contraindicate a blood donation to be performed within four weeks from screening
  5. Any physical condition or laboratory results that require the chemotherapy to start before there is available slot for blood donation
  6. Known or suspected allergic reactions to any ingredient of the IP
  7. Diagnosis or indication of any active autoimmune disease, such as Rheumatoid Arthritis, Inflammatory Bowel Disease, Systemic Lupus Erythematosis or Multiple Sclerosis
  8. 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
  9. Poorly controlled hypertension
  10. Poorly controlled Diabetes Mellitus, type I or II
  11. Diagnosis or indication of any clinically relevant renal disease
  12. Diagnosis or indication of any clinically relevant hepatic disease
  13. Ongoing infection that is considered chronic
  14. Known or suspected drug or alcohol abuse, within 12 months from screening
  15. Pregnant, trying to become pregnant, or nursing
  16. Lack of, or unreliable contraceptive method, as judged by the Investigator
  17. 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
  18. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator

Information from the National Library of Medicine

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


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 141 57
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Hareth Nahi, M.D. Karolinska University Hospital
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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: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hareth Nahi, Karolinska University Hospital:
NK cells
Consolidation
Additional relevant MeSH terms:
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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