Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma

NCT04558853 | Unknown Phase 1

• 1 other identifier: ACP-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

NK cells; Consolidation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes on serum monoclonal immunoglobulin levels as a marker of efficacy

  From date of screening through study completion, up until six months from last infusion

• Changes on urine monoclonal immunoglobulin levels as a marker of efficacy

  From date of screening through study completion, up until six months from last infusion

• Changes on serum free light chain levels as a marker of efficacy

  From date of screening through study completion, up until six months from last infusion

• Effect of CellProtect on plasma cell fraction in bone marrow

  From date of screening up until one month from last infusion

• Response assessment as defined by the International Myeloma Working Group uniform response criteria

  From date of screening up until six months from last infusion

Study Arms (1)

Autologous NK cells

EXPERIMENTAL

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

Interventions

autologous NK cells DRUG

Autologous ex vivo expanded and activated NK cells

Autologous NK cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 141 57, Sweden

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hareth Nahi, M.D.

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 22, 2020
• Study Start: January 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)