T-cell Malignancies Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, IND, ROA, MOA, NDA Approval and Companies involved by DelveInsight

(Albany, USA) DelveInsight's "T-cell Malignancies Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the T-cell malignancies market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging T-cell malignancies drugs, the T-cell malignancies pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

The T-cell malignancies pipeline is advancing rapidly, with leading companies such as Jiangsu Hengrui Medicine, Soligenix, Equillium, Janssen Biotech, Ono Pharmaceutical, and Artiva Biotherapeutics, pioneering innovative therapies aimed at targeting and eliminating malignant T-cells.

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Key Takeaways from the T-cell Malignancies Pipeline Report
• DelveInsight's T-cell malignancies pipeline analysis depicts a robust space with 80+ active players working to develop 82+ pipeline drugs for T-cell malignancies treatment.
• The leading T-cell malignancies companies include AB Science, Corvus Pharmaceuticals, Bristol-Myers Squibb, Kymera Therapeutics, neoX Biotech, Jiangsu Hengrui Medicine, Soligenix, Equillium, Janssen Biotech, Ono Pharmaceutical, Artiva Biotherapeutics, Dialectic Therapeutics, Nutcracker Therapeutics, FutureGen Biopharmaceutical, Step Pharma, Merck & Co., and others are evaluating their lead assets to improve the T-cell malignancies treatment landscape.
• Key T-cell malignancies pipeline therapies in various stages of development include Masitinib, Soquelitinib, Golcadomide, KT-333, NXD02, SHR-2554, Hypericin, EQ-101, Daratumumab, ONO-4685, AB-205, DT-2216, NTX-565, M-131, Dencatistat, Pembrolizumab, and others.
• In February 2025, MB-105, a first-in-class CD5-targeted chimeric antigen receptor T-cell therapy, received orphan drug designation for the treatment of relapsed/refractory CD5-positive T-cell lymphoma. In a Phase I study (NCT03081910), MB-105 showed a promising overall response rate in patients with T-cell lymphoma and T-cell acute lymphoblastic leukemia.
• In January 2025, March Biosciences, Inc., a clinical-stage biotechnology company, announced that its first-in-class autologous CD5-targeting CAR T-cell therapy, MB-105, has received orphan drug designation from the FDA for the treatment of relapsed or refractory T-cell lymphoma.
• In December 2024, Prescient Therapeutics Limited received FDA clearance to proceed with a Phase 2 trial of PTX-100, a promising Ras pathway inhibitor, for the treatment of relapsed and refractory cutaneous T-cell lymphomas.

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T-cell Malignancies Overview
T-cell malignancies are a group of rare and aggressive cancers originating from T-cells, a type of white blood cell crucial for cell-mediated immunity. The development of T-cell malignancies is influenced by a complex interplay of genetic and environmental factors. Genetic mutations, including the dysregulation of cancer-testis genes, B lymphoid tyrosine kinase, and key signaling pathways like Jak-3/STAT and NOTCH1, are often implicated in T-cell lymphoma.

Infections caused by viruses such as Human T-cell leukemia virus (HTLV) 1 and 2, HIV, EBV, CMV, and HHV8 are also associated with T-cell lymphoma, especially adult T-cell lymphoma/leukemia and natural killer/T-cell lymphoma. Chronic conditions, including persistent cutaneous inflammation, and a family history of myeloma, increase the risk of developing T-cell lymphoma. Additionally, autoimmune disorders can contribute to the onset of these cancers, driving the clonal expansion of T-cells and the eventual formation of T-cell lymphomas.

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T-cell Malignancies Treatment Analysis: Drug Profile
Masitinib: AB Science
Masitinib is an orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, key components of the immune system, by inhibiting specific kinases. Due to its unique mechanism of action, masitinib has the potential to be developed for a wide range of conditions in oncology, inflammatory diseases, and central nervous system disorders. In oncology, masitinib's immunotherapy effect may improve survival outcomes, either alone or in combination with chemotherapy. It is currently being evaluated in a Phase III clinical trial for the treatment of patients with T-cell malignancies.

Soquelitinib: Corvus Pharmaceuticals
Soquelitinib (previously known as CPI-818) is an investigational oral small molecule designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme predominantly expressed in T cells, which plays a crucial role in T cell and natural killer (NK) cell immune functions. The drug is currently undergoing a Phase II clinical trial to assess its efficacy in treating patients with T-cell malignancies.

Key T-cell Malignancies Therapies and Companies
• Masitinib: AB Science
• Soquelitinib: Corvus Pharmaceuticals
• Golcadomide: Bristol-Myers Squibb
• KT-333: Kymera Therapeutics
• NXD02: neoX Biotech

Learn more about the novel and emerging T-cell malignancies pipeline therapies @ https://www.delveinsight.com/sample-request/t-cell-malignancies-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

T-cell Malignancies Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the T-cell Malignancies Pipeline Report
• Coverage: Global
• Key T-cell Malignancies Companies: AAB Science, Corvus Pharmaceuticals, Bristol-Myers Squibb, Kymera Therapeutics, neoX Biotech, Jiangsu Hengrui Medicine, Soligenix, Equillium, Janssen Biotech, Ono Pharmaceutical, Artiva Biotherapeutics, Dialectic Therapeutics, Nutcracker Therapeutics, FutureGen Biopharmaceutical, Step Pharma, Merck & Co., and others.
• Key T-cell Malignancies Pipeline Therapies: Masitinib, Soquelitinib, Golcadomide, KT-333, NXD02, SHR-2554, Hypericin, EQ-101, Daratumumab, ONO-4685, AB-205, DT-2216, NTX-565, M-131, Dencatistat, Pembrolizumab, and others.

Dive deep into rich insights for drugs used for T-cell malignancies treatment; visit @ https://www.delveinsight.com/sample-request/t-cell-malignancies-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. Executive Summary
3. T-cell Malignancies Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. T-cell Malignancies Pipeline Therapeutics
6. T-cell Malignancies Pipeline: Late-Stage Products (Phase III)
7. T-cell Malignancies Pipeline: Mid-Stage Products (Phase II)
8. T-cell Malignancies Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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