Immune cell therapy tested for tough childhood cancers
NCT ID NCT03420963
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a treatment using donated natural killer (NK) cells from cord blood, combined with chemotherapy, for children and young adults with solid tumors that returned or didn't respond to standard care. The goal was to find the safest dose and check for side effects. The study was stopped early, so results are limited.
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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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12 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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12 months to 40 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: * SCREENING: Patients with relapsed or refractory solid tumors and without known curative therapy or therapy proven to proven to prolong survival with acceptable quality of life. * SCREENING: Patients older than 21 years must have a solid tumor considered by study doctor to be of the childhood cancer type. * SCREENING: Performance level as measured by Karnofsky \>= 60% for patients \> 16 years of age or Lansky \>= 60% for patients =\< 16 years of age. * SCREENING: Documentation of measurable or evaluable non-measurable disease. * SCREENING: At least one documented histological verification of solid tumor diagnosis. Can be from original diagnosis or more recent. * ENROLLMENT: Patient must have fully recovered (i.e. returned to baseline) from the clinically significant acute treatment-related toxicities of all prior treatments prior to beginning treatment on this protocol with exceptions of cytopenias resulting from persistent disease, hearing loss and alopecia. * ENROLLMENT: Performance level as measured by Karnofsky \>= 60% for patients \> 16 years of age or Lansky \>= 60% for patients =\< 16 years of age. * ENROLLMENT: Creatinine clearance \>= 60 mL/min/1.73m\^2 (calculated by 24 hour \[h\] urine collection or nuclear glomerular filtration rate \[GFR\] scan if 24 h collection is not possible) or a serum creatinine based on age and gender as follows: * Age, maximum serum creatinine (mg/dL): * 1 month to \< 6 months, male 0.4, female 0.4; * 6 months to \< 1 year, male 0.5, female 0.5; * 1 to \< 2 years, male 0.6, female 0.6; * 2 to \< 6 years, male 0.8, female 0.8; * 6 to \< 10 years, male 1, female 1; * 10 to \< 13 years, male 1.2, female 1.2; * 13 to \< 16 years, male 1.5, female 1.4; * \>= 16 years, male 1.7, female 1.4. * ENROLLMENT: Adequate liver function, defined as: total bilirubin =\< 2 mg/dl * ENROLLMENT: Adequate liver function, as defined as serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x upper limit of normal (ULN) for age (unless Gilbert's disease or abnormal liver function due to primary disease). * ENROLLMENT: Evidence of adequate bone marrow function (defined by absolute neutrophil count \>= 750), unless patient has documented tumor metastasis to the bone marrow or other condition that results in cytopenia without abnormal marrow function. * ENROLLMENT: Evidence of adequate bone marrow function (defined by platelets \>= 50,000), unless patient has documented tumor metastasis to the bone marrow or other condition that results in cytopenia without abnormal marrow function. * ENROLLMENT: Pulmonary symptoms controlled by medication and pulse oximetry \>= 92% on room air. * ENROLLMENT: Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator. (Non-childbearing potential defined as pre-menarche, greater than one year post-menopausal or surgically sterilized). * ENROLLMENT: Confirmation that a cord blood donor which is matched with the recipient at a 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and HLA class II (molecular) antigens. * ENROLLMENT: Signed informed consent and if applicable pediatric assent. Exclusion Criteria: * SCREENING: Primary tumors of the central nervous system. * SCREENING: Chronic corticosteroid dependence that is unable to be weaned to discontinue. * SCREENING: Determined by study doctor that patient is unlikely to meet inclusion criteria after screening. * ENROLLMENT: Uncontrolled arrhythmias or uncontrolled symptoms of cardiac disease noted by screening history and physical. Patients with known cardiac dysfunction should have an ejection fraction (EF) \> 40% documented by echocardiogram (ECHO). * ENROLLMENT: Patients where the burden of pulmonary metastasis, location, or bulkiness of disease may cause high morbidity if localized swelling such as causing uncontrolled symptoms, oxygen dependence, or location near a major bronchi as determined by investigator. * ENROLLMENT: Pregnant females. * ENROLLMENT: Any uncontrolled systemic infection.
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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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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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