Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma

NCT ID: NCT04558853

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2022-12-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

autologous NK cells

Intervention Type: DRUG

Autologous ex vivo expanded and activated NK cells

Interventions

autologous NK cells

Autologous ex vivo expanded and activated NK cells

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hareth Nahi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hareth Nahi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

ACP-001

Identifier Type: -

Identifier Source: org_study_id