Cutaneous T-Cell Lymphoma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Cutaneous T-Cell Lymphoma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Cutaneous T-cell lymphoma Pipeline Insight” report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in Cutaneous T-cell lymphoma pipeline landscape. It covers the Cutaneous T-Cell Lymphoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Cutaneous T-Cell Lymphoma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Stay ahead with the latest insights! Download DelveInsight’s comprehensive Cutaneous T-Cell Lymphoma Pipeline Report to explore emerging therapies, key Cutaneous T-Cell Lymphoma Companies, and future Cutaneous T-Cell Lymphoma treatment landscapes @ Cutaneous T-Cell Lymphoma Pipeline Outlook Report

Key Takeaways from the Cutaneous T-Cell Lymphoma Pipeline Report

  • In February 2025:- Soligenix:– The primary objective of this Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible light.The study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks.
  • In February 2025:- Dren Bio:- This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas.
  • In February 2025:- M.D. Anderson Cancer Center:- The primary objective is to determine the overall response rate (ORR), to ultra-low-dose-total-skin electron beam therapy with brentuximab vedotin (ULD-TSEBT+BV) among patients with stage I-IV mycosis fungoides/Sezary syndrome.
  • DelveInsight’s Cutaneous T-cell lymphoma pipeline report depicts a robust space with 25+ active players working to develop 30+ pipeline therapies for Cutaneous T-cell lymphoma treatment.
  • The leading Cutaneous T-Cell Lymphoma Companies such as HyBryte, Resminostat, Mundipharma International, Shanghai Pharmaceuticals Holding, Moleculin Biotech, Inc., BeiGene, Mundipharma Research Limited, Jiangsu Simcere Biologics Co., Ltd, Teva Pharmaceuticals USA, Pfizer, Galderma R&D, Merck Sharp & Dohme LLC, Bio-Path Holdings, Inc., Kymera Therapeutics, Inc., Karyopharm Therapeutics Inc. and others.
  • Promising Cutaneous T-Cell Lymphoma Pipeline Therapies such as Romidepsin (depsipeptide, FK228), Brentuximab Vedotin, Methotrexate, Bexarotene, and others.

Discover how the Cutaneous T-Cell Lymphoma treatment paradigm is evolving. Access DelveInsight’s in-depth Cutaneous T-Cell Lymphoma Pipeline Analysis for a closer look at promising breakthroughs @ Cutaneous T-Cell Lymphoma Clinical Trials and Studies

Cutaneous T-Cell Lymphoma Emerging Drugs Profile

  • HyBryte: Soligenix

HyBryte™ (synthetic hypericin or SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. Synthetic hypericin sodium, the active ingredient in HyBryte™, has Orphan Drug designation in the United States for the treatment of T-cell lymphoma and CTCL and in Europe for CTCL. HyBryte™ has received Fast Track designation for the treatment of cutaneous t-cell lymphoma in the United States.

  • AFM13: Affimed GmbH

AFM-13 is under development for the treatment of refractory and relapsed Hodgkin lymphoma, CD30+ lymphoma such as transformed mycosis fungoides, peripheral and cutaneous T-cell lymphoma, large B-cell lymphoma, B-cell non-Hodgkin lymphoma, Hodgkin lymphoma combination with check point inhibitors and Hodgkin lymphoma combination with lenalidomide. The drug candidate is administered intravenously. AFM-13 is a bi-specific, tetravalent human antibody, it acts by targeting CD30/CD16A. The drug is currently in Phase II stage of its development for the treatment of Cutaneous T Cell Lymphoma.

  • ASTX660: Otsuka Pharmaceutical Co., Ltd

ASTX660 (Tolinapant) is a novel, orally administered, non-peptidomimetic antagonist of the cellular and X-linked inhibitors of apoptosis proteins (cIAP1/2 and XIAP). Inhibitors of apoptosis proteins (IAPs) are frequently overexpressed in tumor cells and contribute to tumor cell survival and chemo-resistance. By inhibiting IAPs, tolinapant promotes cell death. Tolinapant also acts via a newly described immunomodulatory mechanism, which works to enhance an anti-tumor immune response in T-cell lymphomas. The drug is in Phase I/II for the treatment of CTCL.

  • WUCART007: Wugen

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Currently, the drug is in Phase I stage of its clinical trial for the treatment of CTCL.

The Cutaneous T-Cell Lymphoma pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Cutaneous T-Cell Lymphoma with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Cutaneous T-Cell Lymphoma Treatment.
  • Cutaneous T-Cell Lymphoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Cutaneous T-Cell Lymphoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Cutaneous T-Cell Lymphoma market.

Get a detailed analysis of the latest innovations in the Cutaneous T-Cell Lymphoma pipeline. Explore DelveInsight’s expert-driven report today! @ Cutaneous T-Cell Lymphoma Unmet Needs

Cutaneous T-Cell Lymphoma Companies

HyBryte, Resminostat, Mundipharma International, Shanghai Pharmaceuticals Holding, Moleculin Biotech, Inc., BeiGene, Mundipharma Research Limited, Jiangsu Simcere Biologics Co., Ltd, Teva Pharmaceuticals USA, Pfizer, Galderma R&D, Merck Sharp & Dohme LLC, Bio-Path Holdings, Inc., Kymera Therapeutics, Inc., Karyopharm Therapeutics Inc. and others.

Cutaneous T-Cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical

Cutaneous T-Cell Lymphoma Products have been categorized under various Molecule types such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

Download DelveInsight’s latest report to gain strategic insights into upcoming Cutaneous T-Cell Lymphoma Therapies and key Cutaneous T-Cell Lymphoma Developments @ Cutaneous T-Cell Lymphoma Market Drivers and Barriers, and Future Perspectives

Scope of the Cutaneous T-Cell Lymphoma Pipeline Report

  • Coverage- Global
  • Cutaneous T-Cell Lymphoma Companies:- HyBryte, Resminostat, Mundipharma International, Shanghai Pharmaceuticals Holding, Moleculin Biotech, Inc., BeiGene, Mundipharma Research Limited, Jiangsu Simcere Biologics Co., Ltd, Teva Pharmaceuticals USA, Pfizer, Galderma R&D, Merck Sharp & Dohme LLC, Bio-Path Holdings, Inc., Kymera Therapeutics, Inc., Karyopharm Therapeutics Inc. and others.
  • Cutaneous T-Cell Lymphoma Pipeline Therapies- Romidepsin (depsipeptide, FK228), Brentuximab Vedotin, Methotrexate, Bexarotene, and others.
  • Cutaneous T-Cell Lymphoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Cutaneous T-Cell Lymphoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in Cutaneous T-Cell Lymphoma drug development? Find out in DelveInsight’s exclusive Cutaneous T-Cell Lymphoma Pipeline Report—access it now! @ Cutaneous T-Cell Lymphoma Emerging Drugs and Major Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. Cutaneous T-Cell Lymphoma: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Cutaneous T-Cell Lymphoma– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Drug Name: Company Name
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. AFM13: Affimed GmbH
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. WUCART007: Wugen
  15. Drug profiles in the detailed report…..
  16. Preclinical Stage Products
  17. Drug Name: Company Name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Cutaneous T-Cell Lymphoma Key Companies
  21. Cutaneous T-Cell Lymphoma Key Products
  22. Cutaneous T-Cell Lymphoma- Unmet Needs
  23. Cutaneous T-Cell Lymphoma- Market Drivers and Barriers
  24. Cutaneous T-Cell Lymphoma- Future Perspectives and Conclusion
  25. Cutaneous T-Cell Lymphoma Analyst Views
  26. Cutaneous T-Cell Lymphoma Key Companies
  27. Appendix

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