Evidence map›Paper›PMID 36255386›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023

Favorable Activity and Safety Profile of Memory-Enriched CD19-Targeted Chimeric Antigen Receptor T-Cell Therapy in Adults with High-Risk Relapsed/Refractory ALL.

Ibrahim Aldoss, Samer K Khaled, Xiuli Wang, Joycelynne Palmer, Yan Wang, Jamie R Wagner, Mary C Clark, Jennifer Simpson, Jinny Paul, Vibhuti Vyas and 12 more

Open access · bronzeAbstract readEditorialComment
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

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  20. Presetting CAR-T cells during ex vivo biomanufacturing.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 2 institutions in 1 country.

Ibrahim Aldoss *Hematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0001-9564-4498
Samer K Khaled *Hematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0003-3554-4625
Xiuli Wang *Hematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0001-5964-4327
Joycelynne PalmerHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0001-6480-7557
Yan WangHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0002-3345-600X
Jamie R WagnerHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0001-7961-3253
Mary C ClarkHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0003-1672-2684
Jennifer SimpsonHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0001-8423-1604
Jinny PaulHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0002-6863-6406
Vibhuti VyasHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0001-6771-5666
Sheng-Hsuan ChienHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0002-4820-8500
Anthony SteinHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0002-1786-1398
Vinod PullarkatHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0001-9129-3424
Amandeep SalhotraHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0002-9302-5041
Monzr M Al MalkiHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0001-8226-471X
Ahmed AribiDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope, Duarte, California.
Karamjeet SandhuDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope, Duarte, California.
Sandra H ThomasHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0002-0735-2194
Lihua E BuddeHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0003-1464-5494
Guido MarcucciHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0002-3983-5908
Christine E BrownHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0003-4915-8207
Stephen J FormanHematological Malignancies Research Institute, City of Hope, Duarte, California.ORCID 0000-0002-2803-4152
City of Hope · USCity Of Hope National Medical Center · US

Funding

Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI XIWEI WU · 1985 to 2026
$86.3M
NCI NIH HHS P30 CA033572
6 · The paper itself

Abstract

purposeA phase I/II study evaluating the safety and activity of memory-enriched CD19-directed chimeric antigen receptor (CD19-CAR) T cells in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). PATIENTS AND

methodsIn phase I, we tested sequentially two cell populations for CAR transduction: (i) central memory (Tcm) or (ii) naïve, stem, and central memory (Tn/mem) T cells. The study employed an activity constrained for toxicity design to determine the recommended phase II dose (RP2D), which was tested in phase II.

resultsThe Tcm cohort was closed early due to lack of activity. The 200 ×106 Tn/mem-derived CD19-CAR T-cell dose was found to be safe and active, and was declared the RP2D. At RP2D, 58 participants underwent leukapheresis and 46 received CD19-CAR T cells. Median age for treated participants was 38 years (range, 22-72). Twenty-nine (63%) participants had relapsed post-allogeneic hematopoietic cell transplantation (alloHCT), 18 (39%) had Philadelphia-like (Ph-like) genotype, and 16 (35%) had extramedullary disease (EMD) at lymphodepletion (LD). Three (7%) participants had grade 3 cytokine release syndrome (CRS), and none had grade ≥ 4 CRS. Eight (17%) participants had grade ≥ 3 neurotoxicity, including one fatal cerebral edema. Forty (87%) patients achieved complete remission (CR)/CR with incomplete hematologic recovery, 2 (4%) progressed, and 4 (9%) were unevaluable for response. Among 42 response-evaluable participants, 16/17 with Ph-like ALL and 13/15 with EMD at LD responded. Twenty-one (53%) responders underwent alloHCT consolidation, which was associated with improved relapse-free survival (adjusted HR = 0.16; 95% confidence interval, 0.05-0.48; P = 0.001).

conclusionsTn/mem-derived CD19-CAR T cells were safe and active, including in Ph-like ALL and EMD. See related commentary by El Marabti and Abdel-Wahab, p. 694.

Indexed as

Hematopoietic Stem Cell TransplantationLymphoma, B-CellReceptors, Chimeric AntigenAdultAgedAntigens, CD19HumansImmunotherapy, AdoptiveMiddle AgedT-LymphocytesYoung AdultAntigens, CD19Receptors, Chimeric Antigen

Identifiers

PMID36255386
PMCPMC10544259
OpenAlexW4306729071

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.