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NCT03003546

Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, LS1681 Trial

Completed Phase 1 Last updated 15 June 2023
What this trial tests

Phase 1 trial testing Laboratory Biomarker Analysis in Recurrent Aggressive Non-Hodgkin Lymphoma in 9 participants. Completed in 16 May 2023.

Timeline
25 April 2019
Primary endpoint
16 May 2023
16 May 2023

Quick facts

Lead sponsorMayo Clinic
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date25 April 2019
Primary completion16 May 2023
Estimated completion16 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Recurrent Aggressive Non-Hodgkin Lymphoma or Recurrent B-Cell Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the best dose and side effects of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)/rituximab-coated nanoparticle AR160 in treating patients with B-cell non-Hodgkin lymphoma that has come back (relapsed) or is not responding to treatment (refractory). Nab-paclitaxel/rituximab-coated nanoparticle AR160 is a combination of paclitaxel albumin-stabilized nanoparticle formulation and rituximab. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel albumin-stabilized nanoparticle formulation and rituximab may work better in treating patients with B-cell non-Hodgkin lymphoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nanomaterials for cancer therapy: current progress and perspectives.
    Cheng Z, Li M, Dey R, Chen Y. · · 2021 · cited 584× · PMID 34059100 · DOI 10.1186/s13045-021-01096-0
  2. Biomedical nanomaterials for immunological applications: ongoing research and clinical trials.
    Lenders V, Koutsoumpou X, Sargsian A, Manshian BB. · · 2020 · cited 59× · PMID 36132021 · DOI 10.1039/d0na00478b
  3. TME-Related Biomimetic Strategies Against Cancer.
    Peng C, Xu Y, Wu J, Wu D, et al · · 2024 · cited 57× · PMID 38192633 · DOI 10.2147/ijn.s441135
  4. Nanopharmaceutics: Part II-Production Scales and Clinically Compliant Production Methods.
    Souto EB, Silva GF, Dias-Ferreira J, Zielinska A, et al · · 2020 · cited 41× · PMID 32143286 · DOI 10.3390/nano10030455
  5. Development of next generation nanomedicine-based approaches for the treatment of cancer: we've barely scratched the surface.
    Tracey SR, Smyth P, Barelle CJ, Scott CJ. · · 2021 · cited 13× · PMID 34709394 · DOI 10.1042/bst20210343
  6. The State of the Art of Theranostic Nanomaterials for Lung, Breast, and Prostate Cancers.
    Freitas LF, Ferreira AH, Thipe VC, Varca GHC, et al · · 2021 · cited 11× · PMID 34685018 · DOI 10.3390/nano11102579
  7. Advances in nano-immunotherapy for hematological malignancies.
    Xu J, Liu W, Fan F, Zhang B, et al · · 2024 · cited 10× · PMID 38796455 · DOI 10.1186/s40164-024-00525-3
  8. Nanotechnology for immuno-oncology.
    Grippin AJ, Lee D, Parkes EE, Jiang W, et al · · 2025 · cited 7× · PMID 40775548 · DOI 10.1038/s43018-025-01025-x

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