Evidence map›Paper›PMID 40610174›Full record

ArticleThe Lancet. Haematology2025

Off-the-shelf induced pluripotent stem-cell-derived natural killer-cell therapy in relapsed or refractory B-cell lymphoma: a multicentre, open-label, phase 1 study.

Paolo Strati, Januario Castro, Aaron Goodman, Veronika Bachanova, Manali Kamdar, Farrukh T Awan, Scott R Solomon, Lilly Wong, Carol Wong, Deepa Patel and 6 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in The Lancet. Haematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Challenges and opportunities of human iPSC-derived NK as "Off-the-shelf" cellular therapies.Journal of experimental & clinical cancer research : CR · 2025
    Review
  10. Advances in Nanobody-Based Platforms for Precision Cancer Diagnosis and Therapy.Polymer science & technology (Washington, D.C.) · 2025
    Review
  11. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Paolo StratiDepartment of Lymphoma and Myeloma and Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: pstrati@mdanderson.org.
Januario CastroMayo Clinic, Phoenix, AZ, USA.
Aaron GoodmanUniversity of California, San Diego, CA, USA.
Veronika BachanovaMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Manali KamdarUniversity of Colorado, Denver, CO, USA.
Farrukh T AwanUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Scott R SolomonNorthside Hospital Cancer Institute, Atlanta, GA, USA.
Lilly WongFate Therapeutics, San Diego, CA, USA.
Carol WongFate Therapeutics, San Diego, CA, USA.
Deepa PatelFate Therapeutics, San Diego, CA, USA.
Cara BickersFate Therapeutics, San Diego, CA, USA.
Wei ZhaoFate Therapeutics, San Diego, CA, USA.
Zahid BashirFate Therapeutics, San Diego, CA, USA.
Bahram ValamehrFate Therapeutics, San Diego, CA, USA.
Rebecca L ElstromFate Therapeutics, San Diego, CA, USA.
Krish PatelSwedish Cancer Institute, Seattle, WA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNatural killer-cell therapies are limited by donor cell sourcing and dose-to-dose variability. FT516 is an induced pluripotent stem cell (iPSC)-derived natural killer-cell therapy expressing high-affinity, non-cleavable CD16 to optimise antibody-dependent cellular cytotoxicity in combination with therapeutic monoclonal antibody. We aimed to assess the safety of FT516 in patients with relapsed or refractory B-cell lymphoma.

methodsThis multicentre, open-label, phase 1 study was conducted at eight research centres in the USA. Eligible patients were aged 18 years or older, had B-cell lymphoma expected to express CD20, with relapsed or refractory disease following at least one previous systemic therapy including anti-CD20 antibody, had measurable disease, and had no treatment options expected to improve survival. Participants received fludarabine (30 mg/m

findingsFrom Oct 11, 2019, to Nov 28, 2022, 56 patients were enrolled, 55 of whom received FT516. 32 (58%) patients were male, 23 (42%) were female, and 43 (78%) were White. The maximum FT516 cell dose (9 × 10

interpretationOur findings suggest that cell therapy using iPSC-derived, gene-modified natural killer cells in combination with monoclonal antibody and IL-2 is safe and active in B-cell malignancies and might address limitations of currently available immune-cell therapies, including manufacturing time, heterogeneity, access, and cost.

fundingFate Therapeutics.

Indexed as

Killer Cells, NaturalLymphoma, B-CellAdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedRecurrence

Identifiers

PMID40610174

What OpenQuestion holds

Textmetadata
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.