Clinical trial · Interventional
Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia
Pilot Study of Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia
NCT00995137CI-TRIAL-00027196completedPhase 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)
This study will determine the maximum tolerated dose of genetically modified natural killer (NK) cells in research participants with relapsed or refractory B-lineage acute lymphoblastic leukemia (ALL).
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 |
|---|---|---|---|
| Lymphoblastic Leukemia, Acute | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK Cell Infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- relapse B-Lineage ALL
- description
- All patients meeting the eligibility criteria. Intervention: NK Cell Infusion
- interventionNames
- Biological: NK Cell Infusion
Primary outcomes (1)
- measure
- This study will determine the maximum tolerated dose of genetically modified NK cells in research participants with relapsed or refractory B-lineage ALL
- timeFrame
- 30 days after the enrollment of the last patient
Secondary outcomes (2)
- measure
- This study will determine the persistence and phenotype of genetically modified NK cells in research participants with relapsed or refractory B-lineage ALL.
- timeFrame
- 30 days after the enrollment of the last patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: less than or equal to 18 years of age. May be greater than 18 years of age if currently a St. Jude patient. * Patients with relapsed or refractory B-lineage ALL who are not eligible for hematopoietic stem cell transplantation (HSCT) because their leukemia is not in remission (\>5% blasts in bone marrow as evidenced either by morphology or by flow cytometry). * Shortening fraction greater than or equal to 25%. * Glomerular filtration rate greater than or equal to 50 cc/min/1.73 m2. * Pulse oximetry greater than or equal to 92% on room air. * Direct bilirubin less than or equal to 3.0 mg/dL. * Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal. * Aspartate transaminases (AST) is no more than 2 times the upper limit of normal. * Karnofsky or Lansky performance score of greater than or equal to 50. * No known allergy to murine products or HAMA testing results within normal limits. * No prior receipt of a gene-transfer agent (e.g. retroviral, adenoviral, lentiviral vector). * Does not have a current pleural or pericardial effusion. * Has a suitable adult family member donor available for NK cell donation. * Has recovered from all acute NCI Common Toxicity Criteria grade II-IV non-hematologic acute toxicities resulting from previous therapy as per the judgment of the principal investigator. * At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy. * Is not receiving more than the equivalent of prednisone 10 mg daily. Exclusion Criteria: * Pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment) * Breastfeeding
References
Publications (1)
- DERIVEDDel Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12. PMID 28054442