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Bortezomib / Chronic Myeloid Leukemia (CML) / NK cells · Phase 1 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 dose-escalation study registration with no posted results. The trial aims to establish the safety and maximum tolerated dose of autologous ex vivo expanded natural killer cells combined with bortezomib in patients with treatment-refractory metastatic solid tumors or hematologic malignancies. No efficacy or safety outcomes are reported in this registry record.
Phase 1, Interventional, Non Randomized, Single Group, Open label, Treatment purpose. Chronic Myeloid Leukemia (CML), Pancreatic Ca, Colon/Rectal Ca, Multiple Myeloma, Carcinoma, Non-Small -Cell Lung; age from 18 Years; to 70 Years. Intervention: 1; 2. n = 35. 1 site: United States.
This is a Phase 1 dose-escalation study registration with no posted results. The trial aims to establish the safety and maximum tolerated dose of autologous ex vivo expanded natural killer cells combined with bortezomib in patients with treatment-refractory metastatic solid tumors or hematologic malignancies. No efficacy or safety outcomes are reported in this registry record.
Registry record contains no results, outcomes, or safety data; results status is unknown.
No clinical impact can be assessed from this registry record, as no results are posted. Clinicians should await peer-reviewed publication of outcomes before considering adoption. The study design is appropriate for Phase 1 but does not establish efficacy.
Phase 1 dose-escalation study with no results posted; establishes safety and feasibility of combined NK cell and bortezomib therapy in treatment-refractory cancers, but is early-stage and uncontrolled.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record, as no results are posted. Clinicians should await peer-reviewed publication of outcomes before considering adoption. The study design is appropriate for Phase 1 but does not establish efficacy.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT00720785). This is a study registration, not published results. Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI). Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 35 participants (ACTUAL). Conditions: Chronic Myeloid Leukemia (CML), Pancreatic Ca, Colon/Rectal Ca, Multiple Myeloma, Carcinoma, Non-Small -Cell Lung. Interventions: DRUG: Bortezomib; BIOLOGICAL: NK cells. Primary outcome measures: safety of escalating NK cell doses of adoptively infused ex vivo expanded autologous NK cells in subjects with treatment refractory metastatic tumors or hematological malignancies that are sensitized to NK cell toxicity with bortezomib. , After each 3 week cycle. Brief summary: Natural killer (NK) cells are white blood cells that have a limited ability to kill cancer cells. This ability might be enhanced if they are given 24 hours after an injection of the drug bortezomib. This study will determine the following: * What dose of NK cells can be given safely to subjects with metastatic solid tumors or leukemia. * The effectiveness and side effects of NK cell therapy * How the body handles NK cells. People between 18 and 70 years of age who have a solid tumor or leukemia, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures: Apheresis to collect NK cells. For this procedure, a catheter (plastic tube) is placed in a vein in the subject s arm. Blood flows from the vein into a cell separator machine, which separates the white cells from the other blood components. The white cells are extracted and the rest of the blood is returned to the body through a second tube placed in a vein in the other arm. Chemotherapy with the drug pentostatin to suppress the immune system and prevent it from attacking the NK cells that will be infused. Chemotherapy with bortezomib to increase NK cell function. Infusion of the NK cells. In this dose-escalating study, successive groups of patients entering the study receive increasingly higher numbers of cells to determine the highest safe dose level. Up to ten dose levels may be studied. Interleukin-2 drug therapy to maintain NK cell activity. Evaluations during therapy including: * Clinical assessment, history and review of medications * Blood draws for routine and research tests. * Pharmacokinetics study after the NK infusion to see how the body handles the cells. For this test, the number of NK cells in the blood are measured over time. This requires drawing about 1 teaspoon of blood at 15 minutes, 30 minutes, 1, 2, 4, 8, 12, and 24 hours after the infusion (day 1); then every 24 hours on days 2 through 7, then once on days 10, 14, and 21. * Bone marrow biopsy (subjects with leukemia only). * Chest x-ray. * CT scan, bone scan and PET scan, if indicated, for disease evaluation. Subjects who respond well after one treatment cycle may be eligible to continue NK cell therapy. ...
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