Clinical trial · Interventional
Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions
HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies
- 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)
The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK-Cell Infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Biological: NK-Cell Infusion
Primary outcomes (1)
- measure
- An evaluation of general safety will be undertaken: · Number of systemic clinical and biological adverse events occurring during the study. · Number of patients who prematurely discontinued study treatment for reasons linked to the general safety.
- timeFrame
- 58 days post infusion of allogeneic NK-cells
Secondary outcomes (5)
- measure
- Duration of donor NK cells in the recipient's blood
- timeFrame
- 58 days post infusion of allogeneic NK-cells
- measure
- Patient survival at 100 days and at one year post treatment (all cause mortality)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have undergone an autologous stem cell transplant for the following diseases: * Acute Myeloid Leukemia * Non-Hodgkin's Lymphoma * Hodgkin's Disease * Multiple Myeloma * Age 13 - 70 years old * Able to give informed consent * Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal * ECOG Performance Status less than or equal to 1 (at planned time of transplantation) * Patients with no active infection Exclusion Criteria: * Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have \> grade 2 toxicity in any organ system) * Patients who have insufficient engraftment parameters according to the following criteria: WBC \< 2,500 /mm3 and platelets \< 50,000/mm3 * Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion. * Intrinsic impaired organ function (as stated above). * Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance. * Uncontrolled, life-threatening infections at the time of infusion. * Concurrent treatment with corticosteroids and/or other immuno-suppressive drugs.
References
Publications (2)
- RESULTKlingemann H, Boissel L. Targeted cellular therapy with natural killer cells. Horm Metab Res. 2008 Feb;40(2):122-5. doi: 10.1055/s-2007-1004576. PMID 18283630
- RESULTKlingemann HG. Natural killer cell-based immunotherapeutic strategies. Cytotherapy. 2005;7(1):16-22. doi: 10.1080/14653240510018000. PMID 16040380