Trial reportAnnals of neurology2018
Neurotoxicity after CTL019 in a pediatric and young adult cohort.
Trial report in Annals of neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01626495 (CHP 959 - A Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leukemia and Lymphoma), which is not on this map. Cited by 69 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
CHP 959 - A Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leukemia and Lymphoma
Who cites it
69 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Monitoring Neurocognitive Functioning After Pediatric Cellular Therapy or Hematopoietic Cell Transplant: Guidelines From the COG Neurocognition in Cellular Therapies Task Force.Transplantation and cellular therapy · 2022Guideline
- Clinical Presentation, Risk Factors, and Outcomes of Immune Effector Cell-Associated Neurotoxicity Syndrome Following Chimeric Antigen Receptor T Cell Therapy: A Systematic Review.Transplantation and cellular therapy · 2022Pooled it
- CD19-targeted chimeric antigen receptor T-cell therapy for CNS relapsed or refractory acute lymphocytic leukaemia: a post-hoc analysis of pooled data from five clinical trials.The Lancet. Haematology · 2021Trial
- HLH-like syndromes associate with increased risk of death and CD19- relapse after CAR T in pediatric B-ALL.Blood advances · 2026Observational
- Roads and detours for CAR T cell therapy in autoimmune diseases.Nature reviews. Drug discovery · 2026Review
- Preinfusion risk factors for the development of severe neurotoxicity following CART therapy in pediatric patients.HemaSphere · 2026Article
- Ready or not, here they come: a practical guide to adoptive T-cell therapies for solid tumors for medical oncologists.The oncologist · 2026Review
- The neurotoxic legacy of CAR-T cells: where do we stand?Therapeutic advances in neurological disorders · 2026Review
- Acute therapy-related toxicities in pediatric acute lymphoblastic leukemia.Haematologica · 2025Review
- Neuroimaging Findings of CAR T-Cell-Associated Neurotoxicity: A Review.Neurology. Clinical practice · 2025Review
- Optimal Production of 3D Neuronal Lineage Population by Morphological Classification.Tissue engineering and regenerative medicine · 2025Article
- Baseline Cognitive and Neurological Status Does Not Modify the Occurrence of ICANS in CAR T-Cell Therapy for Aggressive B-Cell Lymphoma.European journal of neurology · 2025Article
- Acute Symptomatic Seizures During CAR T-Cell Therapy for Hematologic Malignancies: Tri-Site Mayo Clinic Experience.Neurology · 2025Article
- Multicellular Cancer-Stroma Spheres (CSS) for In Vitro Assessment of CAR-T Cell-Associated Toxicity.Cells · 2024Article
- Review
- Riding the storm: managing cytokine-related toxicities in CAR-T cell therapy.Seminars in immunopathology · 2024Review
- Bendamustine lymphodepletion before axicabtagene ciloleucel is safe and associates with reduced inflammatory cytokines.Blood advances · 2024Article
- Chimeric antigen receptor T-cell therapy-induced nervous system toxicity: a real-world study based on the FDA Adverse Event Reporting System database.BMC cancer · 2024Article
- Systemic toxicity of CAR-T therapy and potential monitoring indicators for toxicity prevention.Frontiers in immunology · 2024Review
- INSPIRED Symposium Part 3: Prevention and Management of Pediatric Chimeric Antigen Receptor T Cell-Associated Emergent Toxicities.Transplantation and cellular therapy · 2024Review
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
objectiveTo characterize the incidence and clinical characteristics of neurotoxicity in the month following CTL019 infusion in children and young adults, to define the relationship between neurotoxicity and cytokine release syndrome (CRS), and to identify predictive biomarkers for development of neurotoxicity following CTL019 infusion.
methodsWe analyzed data on 51 subjects, 4 to 22 years old, who received CTL019, a chimeric antigen receptor-modified T-cell therapy against CD19, between January 1, 2010 and December 1, 2015 through a safety/feasibility clinical trial (NCT01626495) at our institution. We recorded incidence of significant neurotoxicity (encephalopathy, seizures, and focal deficits) and CRS, and compared serum cytokine levels in the first month postinfusion between subjects who did and did not develop neurotoxicity.
resultsNeurotoxicity occurred in 23 of 51 subjects (45%, 95% confidence interval = 31-60%) and was positively associated with higher CRS grade (p < 0.0001) but was not associated with demographic characteristics or prior oncologic treatment history. Serum interleukin (IL)-2, IL-15, soluble IL-4, and hepatocyte growth factor concentrations were higher in subjects with neurotoxicity than those with isolated CRS. Differences in peak levels of select cytokines including IL-12 and soluble tumor necrosis factor receptor-1 within the first 3 days were seen in subjects with neurotoxicity.
interpretationNeurotoxicity is common after CTL019 infusion in children and young adults, and is associated with higher CRS grade. Differences in serum cytokine profiles between subjects with neurotoxicity and those with isolated CRS suggest unique pathophysiological mechanisms. Serum cytokine profiles in the first 3 days postinfusion may help identify children and young adults at risk for neurotoxicity, and may provide a foundation for investigation into potential mitigation strategies. Ann Neurol 2018;84:537-546.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.