Immune cells supercharged to fight cancer: early trial shows promise
NCT ID NCT00720785
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 8 times
Summary
This early-phase trial tested whether giving patients their own natural killer (NK) cells, boosted by the drug bortezomib, is safe for treating advanced cancers like leukemia, lung, and pancreatic cancer. Thirty-five adults whose cancers had not responded to standard treatments received NK cell infusions after chemotherapy. The main goal was to find the safest dose and watch for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Natural killer (NK) cells and bortezomib
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced cancers that have not responded to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 35 participants, so it is primarily testing safety, not effectiveness. The approach may not work for all cancer types, and side effects from chemotherapy and cell infusion are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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35 people
The number who actually took part.
- Started
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Aug 2008
- Finished
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Apr 2021
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: 1. Diagnosed with histologically confirmed metastatic solid tumor - cancer of the lung (small cell or non small cell), prostate (adenocarcinoma), colorectum, kidney (renal cell carcinoma), pancreas (adenocarcinoma),or malignant melanoma, metastatic Ewing's sarcoma, or metastatic epithelial neoplasms and adenocarcinoma of unknown primary, and disease confirmed to be metastatic and unresectable for which standard curative or beneficial treatments are no longer effective OR Diagnosed with a hematological malignancy (multiple myeloma, \[MM\] chronic myelogenous leukemia \[CML\] or chronic lymphocytic leukemia \[CLL\] or small lymphocytic lymphoma \[SLL\]) and disease resistant or refractory to standard therapy and CLL/SLL patients are required to have failed prior treatment with at least one nucleoside analogue. Myeloma patients are required to have disease which has progressed following treatment with bortezomib. 2. At least 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational). NOTE: subjects on FDA-approved tyrosine kinase inhibitors or other targeted therapies for RCC such as mTOR inhibitors that have evidence of disease progression on therapy may continue these medicines until the time of study enrollment (as accelerated disease progression following discontinuation of these drugs has been described). 3. At least 2 weeks since prior palliative radiotherapy. 4. Ages greater than or equal to 18 years and less than or equal to 70 years. 5. Evidence of progressive disease over a 3-month interval. 6. RBC transfusion independent (solid tumor patients only). EXCLUSION CRITERIA: 1. Disease not evaluable radiographically (applies to solid tumor patients only). 2. Disease involving greater than 25% of the liver radiographically (estimated based on review of liver lesions seen on CT scan). 3. History of an allogeneic hematopoietic stem cell transplant. 4. Brain metastases (with the exception of patients with a single brain metastasis less than 1cm treated with either sterotactic or gamma knife radiotherapy) due to poor prognosis and potential for neurological dysfunction that would confound evaluation of neurological and other adverse events). 5. Peripheral neuropathy of grade greater than 1, which would require reduction of bortezomib dose. 6. Acute diffuse infiltrative pulmonary disease. 7. Acute pericardial disease. 8. Life expectancy less than 3 months. 9. ECOG performance status 2, 3 or 4. 10. Uncontrolled concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia. Patients with symptoms of coronary artery disease, cardiac arrhythmias or an abnormal thallium stress test must be evaluated and cleared by cardiology prior to enrollment. 11. Ongoing or active infection 12. Contraindication for administration of pentostatin, bortezomib, and/or interleukin-2. 13. Allergy or hypersensitivity to bortezomib, boron or mannitol by history. 14. Concurrent use of corticosteroids. 15. For all tumor types: Marrow function characterized by -Absolute neutrophil count less than 500/mcL (must be present off growth factors) Organ function characterized by * Total bilirubin greater than 3 times upper limit of normal * AST (SGOT)/ALT (SGPT) greater than 4 times upper limit of normal * Creatinine clearance less than 50 cc/min based on a 24 hour urine collection * Left ventricular ejection fraction less than 40% by echocardiogram (ECHO) * Hypercalcemia greater than 2.5 mmol/L For all Hematologic malignancies: Marrow function characterized by * Neutrophil count less than or equal to 500/mcl * Platelets less than or equal to 20,000/mcl 16. HIV-positive patients 17. Hepatitis C positive patients (Hep C PCR positive) 18. Active Hepatitis B infection (Hep B surface antigen positive) 19. Pregnant or nursing 20. Psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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