DelveInsight’s “T-Cell Lymphoma – Pipeline Insight, 2025” highlights a broad spectrum of investigational candidates spanning subtypes such as peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), and anaplastic large cell lymphoma (ALCL). Mid- and late-stage programs feature monoclonal antibodies, antibody-drug conjugates (ADCs), bispecific T-cell engagers, and checkpoint inhibitors designed to enhance tumor-specific immune responses. Chimeric antigen receptor (CAR) T-cell therapies targeting T-cell–specific antigens are also entering clinical evaluation, despite the unique challenges of targeting T-cell malignancies.
Novel agents targeting epigenetic pathways—such as histone deacetylase (HDAC) inhibitors and next-generation bromodomain (BET) inhibitors—are showing promise in modulating tumor gene expression and overcoming chemoresistance. In parallel, therapies focused on tumor microenvironment modulation, cytokine signaling pathways, and combination regimens are advancing to improve efficacy and durability of response.
The 2025 pipeline reflects a paradigm shift toward mechanism-based and disease-modifying strategies, leveraging breakthroughs in immuno-oncology and cellular engineering. With growing regulatory incentives for rare hematological malignancies, rising research collaborations, and targeted investment in T-cell–directed approaches, the next wave of therapies could significantly alter the treatment landscape and long-term outcomes for patients with T-cell lymphoma.
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Key Takeaways from the T-Cell Lymphoma Pipeline Report
• DelveInsight’s T-Cell Lymphoma pipeline analysis depicts a strong space with 90+ active players working to develop 90+ pipeline drugs for T-Cell Lymphoma treatment.
• The leading T-Cell Lymphoma companies include Soligenix, CStone Pharmaceuticals, Genor Biopharma, Innate Pharma, ImmuneOncia Therapeutics, Astex Pharmaceuticals, Corvus Pharmaceuticals, ViGenCell Inc., Affimed GmbH, MediSix Therapeutics, Dialectic Therapeutics, Artiva Biotherapeutics, Inc., and others are evaluating their lead assets to improve the T-Cell Lymphoma treatment landscape.
• Key T-Cell Lymphoma pipeline therapies in various stages of development include SGX 301, Sugemalimab, Geptanolimab, Lacutamab, IMC-001, Tolinapant, CPI-818, VT-EBV-N, AFM-13, PCART3, DT2216, AB-101, and others.
• In April 2025, March Biosciences announced that the FDA granted Orphan Drug Designation to MB-105, a CD5-targeted CAR-T cell therapy for relapsed/refractory CD5-positive T-cell lymphoma, enabling the company to advance the program into Phase II clinical trials early in 2025.
• In June 2025, the FDA eliminated the need for Risk Evaluation and Mitigation Strategies (REMS) for all currently approved CAR-T cell therapies—including those used in T-cell and other lymphomas—simplifying post-marketing requirements and potentially improving access.
• In April 2025, BioInvent received FDA Fast Track Designation for BI-1808, a novel anti-TNFR2 antibody being developed for relapsed/refractory cutaneous T-cell lymphoma (CTCL), recognizing its potential to address a significant unmet need in CTCL treatment.
• In March 2025, the FDA cleared an Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T therapy intended for pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/T-LBL), enabling the launch of first-in-human trials.
T-Cell Lymphoma Overview
T-cell lymphoma is a rare and diverse group of aggressive blood cancers that originate in T lymphocytes, a type of white blood cell that plays a key role in the immune system. It falls under the category of non-Hodgkin lymphomas. It comprises several subtypes, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL), and angioimmunoblastic T-cell lymphoma (AITL), among others. These subtypes differ in symptoms, aggressiveness, and treatment response. Common signs include swollen lymph nodes, fatigue, fever, night sweats, and skin rashes, particularly in cases of CTCL.
T-cell lymphomas are typically more challenging to treat than B-cell lymphomas, with lower survival rates and limited standard treatment options. Therapy often includes chemotherapy, radiation, targeted therapy, and sometimes stem cell transplantation. Research is ongoing to develop more effective treatments, including immunotherapy and novel targeted drugs. Early diagnosis and accurate subtype classification are critical for effective treatment planning and prognosis.
Find out more about T-Cell Lymphoma medication at https://www.delveinsight.com/report-store/t-cell-lymphoma-pipeline-insight
T-Cell Lymphoma Treatment Analysis: Drug Profile
SGX301 (HyBryte™) – Soligenix
SGX301, also known as HyBryte™ (synthetic hypericin), is a novel first-in-class photodynamic therapy designed for early-stage cutaneous T-cell lymphoma (CTCL). It involves the topical application of hypericin ointment, activated by safe visible light. The therapy has received multiple regulatory designations, including Orphan Drug and Fast Track status in the U.S., Orphan Drug designation in the EU, and Promising Innovative Medicine (PIM) status from the UK’s health authority. Soligenix has submitted a New Drug Application (NDA) to the FDA for HyBryte™ for treating early-stage CTCL.
Sugemalimab – CStone Pharmaceuticals
Sugemalimab is an investigational fully human anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals. Its IgG4-type structure minimizes immunogenicity and potential toxicity. In September 2022, China’s National Medical Products Administration (NMPA) accepted and granted priority review to the supplemental NDA for sugemalimab for treating relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL).
IMC-001 – ImmuneOncia Therapeutics
IMC-001 (STI-3031) is a fully human IgG1 anti-PD-L1 monoclonal antibody being developed for NK/T-cell lymphoma. It has demonstrated encouraging safety and efficacy in early clinical trials involving heavily pretreated patients. Its IgG1 format allows for unique combination strategies, including with natural killer (NK) cell-based therapies, offering potential advantages over other PD-1/PD-L1 agents. IMC-001 is currently in Phase II development.
Learn more about the novel and emerging T-Cell Lymphoma pipeline therapies.
T-Cell Lymphoma 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
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule
Scope of the T-Cell Lymphoma Pipeline Report
• Coverage: Global
• Key T-Cell Lymphoma Companies: Soligenix, CStone Pharmaceuticals, Genor Biopharma, Innate Pharma, ImmuneOncia Therapeutics, Astex Pharmaceuticals, Corvus Pharmaceuticals, ViGenCell Inc., Affimed GmbH, MediSix Therapeutics, Dialectic Therapeutics, Artiva Biotherapeutics, Inc., and others.
• Key T-Cell Lymphoma Pipeline Therapies: SGX 301, Sugemalimab, Geptanolimab, Lacutamab, IMC-001, Tolinapant, CPI-818, VT-EBV-N, AFM-13, PCART3, DT2216, AB-101, and others.
Explore detailed insights on drugs used in the treatment of T-Cell Lymphomas here.
Table of Contents
1. Introduction
2. Executive Summary
3. T-Cell Lymphoma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. T-Cell Lymphoma Pipeline Therapeutics
6. T-Cell Lymphoma Pipeline: Late-Stage Products (Phase III)
7. T-Cell Lymphoma Pipeline: Mid-Stage Products (Phase II)
8. T-Cell Lymphoma 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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