Evidence map›Paper›PMID 37511562›Full record

ReviewInternational journal of molecular sciences2023

CAR-T State of the Art and Future Challenges, A Regulatory Perspective.

Lorenzo Giorgioni, Alessandra Ambrosone, Maria Francesca Cometa, Anna Laura Salvati, Armando Magrelli

Registry-linked trialAbstract readReview
In one paragraph

Review in International journal of molecular sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03391466 (A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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.

NCT03391466 phase3completednot on this map

A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)

TypeinterventionalSponsorKite, A Gilead CompanyRan2018 to 2024Enrolled359ConditionsRelapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)ArmsAxicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy, Cyclophosphamide, Fludarabine
3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review
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

5 authors.

Lorenzo GiorgioniFaculty of Physiology and Pharmacology "V. Erspamer", Sapienza Università di Roma, 00185 Rome, Italy.ORCID 0009-0000-2428-6726
Alessandra AmbrosoneFaculty of Medicine and Pharmacy, Sapienza Università di Roma, 00185 Rome, Italy.
Maria Francesca CometaNational Center for Drug Research and Evaluation, Istituto Superiore di Sanità, 00161 Rome, Italy.
Anna Laura SalvatiFaculty of Pharmacy, Tor Vergata University of Rome, 00133 Rome, Italy.
Armando MagrelliNational Center for Drug Research and Evaluation, Istituto Superiore di Sanità, 00161 Rome, Italy.ORCID 0000-0002-5036-3710

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This review is an outlook on CAR-T development up to the beginning of 2023, with a special focus on the European landscape and its regulatory field, highlighting the main features and limitations affecting this innovative therapy in cancer treatment. We analysed the current state of the art in the EU and set out a showcase of the field's potential advancements in the coming years. For this analysis, the data used came from the available scientific literature as well as from the European Medicines Agency and from clinical trial databases. The latter were investigated to query the studies on CAR-Ts that are active and/or relevant to the review process. As of this writing, CAR-Ts have started to move past the "ceiling" of third-line treatment with positive results in comparison trials with the Standard of Care (SoC). One such example is the trial Zuma-7 (NCT03391466), which resulted in approval of CAR-T products (Yescarta™) for second-line treatment, a crucial achievement for the field which can increase the use of this type of therapy. Despite exciting results in clinical trials, limitations are still many: they regard access, production, duration of response, resistance, safety, overall efficacy, and cost mitigation strategies. Nonetheless, CAR-T constructs are becoming more diverse, and the technology is starting to produce some remarkable results in treating diseases other than cancer.

Indexed as

NeoplasmsReceptors, Chimeric AntigenClinical Trials as TopicHumansImmunotherapy, AdoptiveTechnologyReceptors, Chimeric AntigenATMPCAR-Tcompassionate useEMAhospital exemptionrare diseases

Identifiers

PMID37511562
PMCPMC10380644

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.