Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Safety Study of CellProtect, an Autologous ex Vivo Expanded and Activated Natural Killer (NK) Cell Product, in Patients With Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04558853
• Other study ID #: ACP-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 1, 2014
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• autologous NK cells
Autologous ex vivo expanded and activated NK cells

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose of study treatment up until six months from last infusion.
Secondary	Changes on serum monoclonal immunoglobulin levels as a marker of efficacy	Changes in absolute and relative levels of laboratory parameters	From date of screening through study completion, up until six months from last infusion
Secondary	Changes on urine monoclonal immunoglobulin levels as a marker of efficacy	Changes in absolute and relative levels of laboratory parameters	From date of screening through study completion, up until six months from last infusion
Secondary	Changes on serum free light chain levels as a marker of efficacy	Changes in absolute and relative levels of laboratory parameters	From date of screening through study completion, up until six months from last infusion
Secondary	Effect of CellProtect on plasma cell fraction in bone marrow	Changes in bone marrow clonal plasma cells	From date of screening up until one month from last infusion
Secondary	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	From date of screening up until six months from last infusion