Clinical trial NCT04558853: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: NK cells
Consolidation
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: From first dose of study treatment up until six months from last infusion.
Secondary outcomes:
measure: Changes on serum monoclonal immunoglobulin levels as a marker of efficacy
timeFrame: From date of screening through study completion, up until six months from last infusion
measure: Changes on urine monoclonal immunoglobulin levels as a marker of efficacy
timeFrame: From date of screening through study completion, up until six months from last infusion
measure: Changes on serum free light chain levels as a marker of efficacy
timeFrame: From date of screening through study completion, up until six months from last infusion
measure: Effect of CellProtect on plasma cell fraction in bone marrow
timeFrame: From date of screening up until one month from last infusion
measure: Response assessment as defined by the International Myeloma Working Group uniform response criteria
timeFrame: From date of screening up until six months from last infusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Hareth Nahi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: