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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous NK cells | Drug | Autologous ex vivo expanded and activated NK cells |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes on urine monoclonal immunoglobulin levels as a marker of efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hareth Nahi, M.D. | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 141 57 | Sweden |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 14, 2023 | |
| Reset | Nov 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 14, 2023 | Nov 22, 2023 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Changes in absolute and relative levels of laboratory parameters |
| 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 | Changes in absolute and relative levels of laboratory parameters | From date of screening through study completion, up until six months from last infusion |
| 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 |
| 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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |