Clinical trial · Interventional
Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma
A Safety Study of CellProtect, an Autologous ex Vivo Expanded and Activated Natural Killer (NK) Cell Product, in Patients With Multiple Myeloma
NCT04558853CI-TRIAL-00050125unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous NK cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous NK cells
- description
- 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
- interventionNames
- Drug: autologous NK cells
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- timeFrame
- From first dose of study treatment up until six months from last infusion.
- description
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.