Evidence map›Paper›PMID 39946666›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies.

Frederick L Locke, Javier L Munoz, Michael T Tees, Lazaros J Lekakis, Sven de Vos, Rajneesh Nath, Don A Stevens, Shahbaz A Malik, Geoffrey P Shouse, Mehdi Hamadani and 8 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
–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.

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

25 citing papers in PubMed.

  1. Review
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  10. Beyond autologousMolecular therapy. Oncology · 2026
    Review
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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

18 authors.

Frederick L LockeMoffitt Cancer Center and Research Institute, Tampa, FL.ORCID 0000-0001-9063-6691
Javier L MunozMayo Clinic, Phoenix, AZ.ORCID 0000-0002-9060-8911
Michael T TeesColorado Blood Cancer Institute/Sarah Cannon Research Institute, Denver, CO.
Lazaros J LekakisUniversity of Miami Health System, Sylvester Comprehensive Cancer Center, Miami, FL.
Sven de VosUniversity of California, Los Angeles, Los Angeles, CA.
Rajneesh NathBanner MD Anderson Cancer Center, Scottsdale, AZ.
Don A StevensNorton Cancer Institute, Louisville, KY.
Shahbaz A MalikSt David's South Austin Medical Center, Austin, TX.
Geoffrey P ShouseCity of Hope National Medical Center, Duarte, CA.ORCID 0000-0002-7917-5713
Mehdi HamadaniMedical College of Wisconsin, Milwaukee, WI.ORCID 0000-0001-5372-510X
Olalekan O OluwoleVanderbilt University Medical Center, Nashville, TN.ORCID 0000-0001-8525-9641
Miguel-Angel PeralesMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5910-4571
David B MiklosStanford University School of Medicine, Stanford, CA.ORCID 0000-0003-0717-4305
Paul W FisherAllogene Therapeutics, San Francisco, CA.ORCID 0000-0003-4153-1935
Amy FengAllogene Therapeutics, San Francisco, CA.
Lynn NavaleAllogene Therapeutics, San Francisco, CA.
John B Le GallAllogene Therapeutics, San Francisco, CA.ORCID 0000-0002-6558-6108
Sattva S NeelapuThe University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-1045-4914

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeOff-the-shelf, allogeneic CD19 chimeric antigen receptor (CAR) T-cell products may improve access to treatment versus autologous ones. We report the phase I experience of the allogeneic CD19 CAR T-cell product cemacabtagene ansegedleucel (cema-cel) and its predecessor, ALLO-501, in CD19 CAR T-naïve patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).

methodsIn the ALPHA2/ALPHA studies, the safety and efficacy of allogeneic CD19 CAR T cells were evaluated in CD19 CAR T treatment-naïve patients with R/R LBCL. Patients received healthy donor-derived, human leukocyte antigen-unmatched cema-cel/ALLO-501 following a 3-day lymphodepletion regimen of fludarabine (30 mg/m

resultsAs of September 26, 2024, 33 CD19 CAR T-naïve patients with LBCL (median age, 66 years; median number of previous therapies, 3) received allogeneic CAR T cells. CAR T-cell expansion was observed following infusion, with persistence observed up to 4 months. The overall and complete response (CR) rates were 58% and 42%, respectively; the median duration of response in patients with a CR was 23.1 months. The most common treatment-emergent adverse events were hematologic toxicities. No cases of graft-versus-host disease, immune effector cell-associated neurotoxicity syndrome, or grade ≥3 cytokine release syndrome were reported.

conclusionAllogeneic CD19 CAR T cells demonstrated promising overall and durable CR rates with a manageable safety profile in CD19 CAR T-naïve patients with R/R LBCL, supporting additional evaluation of cema-cel in patients with LBCL.

Indexed as

Immunotherapy, AdoptiveLymphoma, Large B-Cell, DiffuseReceptors, Chimeric AntigenAdultAgedAntigens, CD19FemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalAntigens, CD19Receptors, Chimeric Antigen

Identifiers

PMID39946666
PMCPMC12058369

What OpenQuestion holds

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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.