Evidence map›Paper›PMID 35603278›Full record

ArticleCommunications medicine2022

Patient-reported outcomes and neurotoxicity markers in patients treated with bispecific LV20.19 CAR T cell therapy.

Jennifer M Knight, Aniko Szabo, Igli Arapi, Ruizhe Wu, Amanda Emmrich, Edward Hackett, Garrett Sauber, Sharon Yim, Bryon Johnson, Parameswaran Hari and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Communications medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03019055 (Phase 1/1b Study of Redirected Autologous T Cells Engineered to Contain an Anti CD19 and Anti CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed and/or Refractory CD19 or CD20 Positive B Cell Malignancies), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03019055 phase1completednot on this map

Phase 1/1b Study of Redirected Autologous T Cells Engineered to Contain an Anti CD19 and Anti CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed and/or Refractory CD19 or CD20 Positive B Cell Malignancies

TypeinterventionalSponsorMedical College of WisconsinRan2017 to 2021Enrolled26ConditionsLymphoma, Non-Hodgkin, Lymphoma, B-Cell, Chronic Lymphocytic Leukemia, Small Lymphocytic LymphomaArmsCAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 3 institutions in 1 country.

Jennifer M KnightDepartment of Psychiatry, Medical College of Wisconsin, Milwaukee, WI USA.ORCID 0000-0002-9140-3109
Aniko SzaboDivision of Biostatistics, Medical College of Wisconsin, Milwaukee, WI USA.
Igli ArapiDepartment of Psychiatry, Medical College of Wisconsin, Milwaukee, WI USA.
Ruizhe WuDivision of Biostatistics, Medical College of Wisconsin, Milwaukee, WI USA.
Amanda EmmrichDepartment of Psychiatry, Medical College of Wisconsin, Milwaukee, WI USA.
Edward HackettMedical College of Wisconsin, Milwaukee, WI USA.
Garrett SauberDepartment of Pharmacology and Toxicology and Neuroscience Research Center, Medical College of Wisconsin, Milwaukee, WI USA.
Sharon YimBMT & Cellular Therapy Program, Division of Hematology & Oncology, Medical College of Wisconsin, Milwaukee, WI USA.ORCID 0000-0001-6442-1320
Bryon JohnsonBMT & Cellular Therapy Program, Division of Hematology & Oncology, Medical College of Wisconsin, Milwaukee, WI USA.
Parameswaran HariBMT & Cellular Therapy Program, Division of Hematology & Oncology, Medical College of Wisconsin, Milwaukee, WI USA.ORCID 0000-0002-8800-297X
Dina SchneiderLentigen, a Miltenyi Biotec company, Gaithersburg, MD USA.
Boro DropulicLentigen, a Miltenyi Biotec company, Gaithersburg, MD USA.
Rachel N CusatisDepartment of Medicine, Division of Hematology & Oncology, Medical College of Wisconsin, Milwaukee, WI USA.
Steve W ColeDepartments of Psychiatry and Biobehavioral Sciences and Medicine, Division of Hematology-Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA USA.
Cecilia J Hillard *Department of Pharmacology and Toxicology and Neuroscience Research Center, Medical College of Wisconsin, Milwaukee, WI USA.ORCID 0000-0002-9678-748X
Nirav N Shah *BMT & Cellular Therapy Program, Division of Hematology & Oncology, Medical College of Wisconsin, Milwaukee, WI USA.ORCID 0000-0002-4336-1071
Medical College of Wisconsin · USLentigen Technology (United States) · USNeurobehavioral Systems · US

Funding

NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
Clinical and Translational Science AwardUL1TR001436 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI FREED, JULIE K · 2015 to 2025
$47.5M
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical TrialsUG1CA233193 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Muhammad Furqan · 2019 to 2026
$13.7M
Institutional Career Development CoreKL2TR001438 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI WIDLANSKY, MICHAEL E · 2015 to 2024
$2.9M
NCATS NIH HHS KL2 TR001438NCATS NIH HHS UL1 TR001436NCI NIH HHS UG1 CA233193
6 · The paper itself

Abstract

Background: With the rising number of chimeric antigen receptor (CAR) T cell treated patients, it is increasingly important to understand the treatment's impact on patient-reported outcomes (PROs) and, ideally, identify biomarkers of central nervous system (CNS) adverse effects. Methods: The purpose of this exploratory study was to assess short-term PROs and serum kynurenine metabolites for associated neurotoxicity among patients treated in an anti-CD20, anti-CD19 (LV20.19) CAR T cell phase I clinical trial (NCT03019055). Fifteen CAR T treated patients from the parent trial provided serum samples and self-report surveys 15 days before and 14, 28, and 90 days after treatment. Results: Blood kynurenine concentrations increased over time in patients with evidence of neurotoxicity ( Conclusions: Elevated levels of kynurenine pathway metabolites among CAR T cell recipients are associated with depressed mood and neurotoxicity. Findings from this exploratory study are preliminary and warrant validation in a larger cohort.

Indexed as

Cancer immunotherapyPredictive markers

Identifiers

PMID35603278
PMCPMC9098435
OpenAlexW4280495736

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Registered trials

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.