Evidence map›Paper›PMID 35349631›Full record

Trial reportBlood advances2022

Anti-CD19 CAR T cells in combination with ibrutinib for the treatment of chronic lymphocytic leukemia.

Saar Gill, Vanessa Vides, Noelle V Frey, Elizabeth O Hexner, Susan Metzger, Megan O'Brien, Wei-Ting Hwang, Jennifer L Brogdon, Megan M Davis, Joseph A Fraietta and 16 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02640209 (Pilot Trial of Autologous T Cells Engineered to Express Anti-CD19 Chimeric Antigen Receptor), which is not on this map. Cited by 87 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02640209 early_phase1terminatednot on this map

Pilot Trial of Autologous T Cells Engineered to Express Anti-CD19 Chimeric Antigen Receptor (CART19) in Combination With Ibrutinib in Patients With Relapsed or Refractory CD19+ CLL or SLL

TypeinterventionalSponsorUniversity of PennsylvaniaRan2016 to 2019Enrolled20ConditionsLYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)ArmsCART 19
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Advancing Immunotherapy in Chronic Lymphocytic Leukemia.International journal of molecular sciences · 2026
    Review
  15. Review
  16. Article
  17. Review
  18. Ibrutinib and PD-1 Blockade Potentiate Mesothelin-Targeting CAR T-cell Therapy in Preclinical Models of Pancreatic Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  19. Article
  20. Review

27 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Saar GillCell Therapy and Transplant Program, Division of Hematology-Oncology and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Vanessa VidesPennsylvania State University College of Medicine, Hershey, PA.
Noelle V FreyCell Therapy and Transplant Program, Division of Hematology-Oncology and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.ORCID 0000-0003-3688-9836
Elizabeth O HexnerCell Therapy and Transplant Program, Division of Hematology-Oncology and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.ORCID 0000-0002-1125-4060
Susan MetzgerCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Megan O'BrienCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Wei-Ting HwangDepartment of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA.
Jennifer L BrogdonNovartis Institutes for Biomedical Research, Cambridge, MA.
Megan M DavisCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.ORCID 0000-0003-4221-7876
Joseph A FraiettaCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Avery L GaymonCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Whitney L GladneyCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Simon F LaceyCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Anne LamontagneCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Anthony R MatoCell Therapy and Transplant Program, Division of Hematology-Oncology and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Marcela V MausCellular Immunotherapy Program, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.ORCID 0000-0002-7578-0393
J Joseph MelenhorstCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.ORCID 0000-0001-7677-537X
Edward PequignotCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Marco RuellaCell Therapy and Transplant Program, Division of Hematology-Oncology and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Maksim ShestovCell Therapy and Transplant Program, Division of Hematology-Oncology and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
John C ByrdDivision of Hematology, The Ohio State University, Columbus, OH.
Stephen J SchusterCell Therapy and Transplant Program, Division of Hematology-Oncology and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.ORCID 0000-0002-3376-8978
Donald L SiegelCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
Bruce L LevineCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.ORCID 0000-0001-6971-8465
Carl H JuneCenter for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, PA.
David L PorterCell Therapy and Transplant Program, Division of Hematology-Oncology and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.

Funding

Project 3: Combinatorial and gene-editing approaches to enhance the efficacy of CAR T cell therapy of multiple myeloma.P01CA214278 · NCI · UNIVERSITY OF PENNSYLVANIA · PI Joseph Anthony Fraietta · 2017 to 2026
$26.8M
MODULATION OF CD5 SIGNALING TO ENHANCE ADOPTIVE T-CELL THERAPIES FOR CANCERR37CA262362 · NCI · UNIVERSITY OF PENNSYLVANIA · PI Marco Ruella · 2022 to 2026
$2.6M
Resistance To Targeted Immunotherapies:CART19 as a ParadigmR00CA212302 · NCI · UNIVERSITY OF PENNSYLVANIA · PI RUELLA, MARCO · 2018 to 2020
$608k
Resistance To Targeted Immunotherapies:CART19 as a ParadigmK99CA212302 · NCI · UNIVERSITY OF PENNSYLVANIA · PI RUELLA, MARCO · 2017 to 2018
$348k
NCI NIH HHS K99 CA212302NCI NIH HHS P01 CA214278NCI NIH HHS R00 CA212302
6 · The paper itself

Abstract

In chronic lymphocytic leukemia (CLL) patients who achieve a complete remission (CR) to anti-CD19 chimeric antigen receptor T cells (CART-19), remissions are remarkably durable. Preclinical data suggesting synergy between CART-19 and the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib prompted us to conduct a prospective single-center phase 2 trial in which we added autologous anti-CD19 humanized binding domain T cells (huCART-19) to ibrutinib in patients with CLL not in CR despite ≥6 months of ibrutinib. The primary endpoints were safety, feasibility, and achievement of a CR within 3 months. Of 20 enrolled patients, 19 received huCART-19. The median follow-up for all infused patients was 41 months (range, 0.25-58 months). Eighteen patients developed cytokine release syndrome (CRS; grade 1-2 in 15 of 18 subjects), and 5 developed neurotoxicity (grade 1-2 in 4 patients, grade 4 in 1 patient). While the 3-month CR rate among International Working Group on CLL (iwCLL)-evaluable patients was 44% (90% confidence interval [CI], 23-67%), at 12 months, 72% of patients tested had no measurable residual disease (MRD). The estimated overall and progression-free survival at 48 months were 84% and 70%, respectively. Of 15 patients with undetectable MRD at 3 or 6 months, 13 remain in ongoing CR at the last follow-up. In patients with CLL not achieving a CR despite ≥6 months of ibrutinib, adding huCART-19 mediated a high rate of deep and durable remissions. ClinicalTrials.gov number, NCT02640209.

Indexed as

Leukemia, Lymphocytic, Chronic, B-CellAdenineAntigens, CD19Disease-Free SurvivalHumansNeoplasm, ResidualPiperidinesProspective StudiesPyrazolesPyrimidinesT-LymphocytesAdenineAntigens, CD19ibrutinibPiperidinesPyrazolesPyrimidines

Identifiers

PMID35349631
PMCPMC9647791

What OpenQuestion holds

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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.