NCT02192021: MNA-D

Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL)

Completed Phase 1 Last updated 9 August 2024

What this trial tests

Phase 1 trial testing Micro needle array-Doxorubicin (MNA-D) in Cutaneous T Cell Lymphoma in 20 participants. Completed in 9 December 2020.

Timeline

9 March 2016

Primary endpoint
21 November 2020

9 December 2020

Quick facts

Lead sponsor	Falo, Louis, MD
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	9 March 2016
Primary completion	21 November 2020
Estimated completion	9 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Micro needle array-Doxorubicin (MNA-D) — full drug profile →

Conditions studied

• Cutaneous T Cell Lymphoma — all drugs for Cutaneous T Cell Lymphoma →

Sponsor

Falo, Louis, MD — full company profile →

Who can join

18 and older, any sex, with Cutaneous T Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study hypothesis is that in situ MNA-directed chemo-immunotherapy using doxorubicin will kill tumor cells locally and alter the tumor microenvironment to induce durable systemic tumor-specific immunity.

The purpose of this study is to test a new method of experimental treatment for CTCL, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. We also want to determine which micro-dose of the drug is the best to achieve the best response. To make sure that we observe the effects of the very low dose of the drug and not the MNA patch itself, we will also use a placebo (a patch without drug in some patients) in addition to the doxorubicin coated patches. We will thoroughly evaluate the skin where the patches are applied. Once the best dose is determined for use in the patch, we will also begin to look at how well the patches work in clearing the skin.

Publications & conference data

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

1. Microneedle array delivered recombinant coronavirus vaccines: Immunogenicity and rapid translational development.
   Kim E, Erdos G, Huang S, Kenniston TW, et al · · 2020 · cited 261× · PMID 32249203 · DOI 10.1016/j.ebiom.2020.102743
2. The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies.
   Frederiksen LSF, Zhang Y, Foged C, Thakur A. · · 2020 · cited 164× · PMID 32793245 · DOI 10.3389/fimmu.2020.01817
3. Dissolving undercut microneedle arrays for multicomponent cutaneous vaccination.
   Balmert SC, Carey CD, Falo GD, Sethi SK, et al · · 2020 · cited 89× · PMID 31756393 · DOI 10.1016/j.jconrel.2019.11.023
4. Coating Materials to Increase the Stability of Liposomes.
   Pasarin D, Ghizdareanu AI, Enascuta CE, Matei CB, et al · · 2023 · cited 84× · PMID 36772080 · DOI 10.3390/polym15030782
5. Microneedle Array: Applications, Recent Advances, and Clinical Pertinence in Transdermal Drug Delivery.
   Halder J, Gupta S, Kumari R, Gupta GD, et al · · 2021 · cited 63× · PMID 32837607 · DOI 10.1007/s12247-020-09460-2
6. Microneedle Arrays Combined with Nanomedicine Approaches for Transdermal Delivery of Therapeutics.
   Alimardani V, Abolmaali SS, Yousefi G, Rahiminezhad Z, et al · · 2021 · cited 53× · PMID 33419118 · DOI 10.3390/jcm10020181
7. The changing therapeutic landscape, burden of disease, and unmet needs in patients with cutaneous T-cell lymphoma.
   Scarisbrick JJ, Bagot M, Ortiz-Romero PL. · · 2021 · cited 29× · PMID 33095448 · DOI 10.1111/bjh.17117
8. Improved Cutaneous Genetic Immunization by Microneedle Array Delivery of an Adjuvanted Adenovirus Vaccine.
   Erdos G, Balmert SC, Carey CD, Falo GD, et al · · 2020 · cited 24× · PMID 32330464 · DOI 10.1016/j.jid.2020.03.966