Chimeric Antigen Receptor T-Cell Therapy (CAR-T) - Pipeline Insight, 2025

The “Chimeric Antigen Receptor T-Cell Therapy (CAR-T) - Pipeline Insight, 2025” report provides comprehensive insights about 180+ companies and 200+ pipeline drugs in Chimeric Antigen Receptor T-Cell Therapy (CAR-T) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Chimeric Antigen Receptor T-Cell Therapy (CAR-T): Understanding

Chimeric Antigen Receptor T-Cell Therapy (CAR-T): Overview

CAR T-cells are the fusion proteins of a selected single-chain fragment variable from a specific monoclonal antibody and one or more T-cell receptor intracellular signaling domains. A CAR combines antigen-binding domains-most commonly, a single-chain variable fragment (scFv) derived from the variable domains of antibodies with the signalling domains of the TCR chain and additional costimulatory domains from receptors, such as CD28, OX40, and CD137. CAR T cells may not only eradicate all cancer cells in the body, but they may remain in the body months after the infusion. T cells are white blood cells that find and fight illness and infection throughout the body. Each T cell has a receptor that can recognize antigens (proteins or molecules that are recognizable by the immune system). When the immune system recognizes foreign or abnormal antigens, it can work to destroy them. Since the initial development of CARs in 1989, CAR T-cells can be divided into four generations, according to the intracellular domain structure.

First-generation CARs comprised of the ζ (zeta) chain of complex TCR/CD3 (CD3ζ).

Second-generation CARs are characterized by the dual signal for T-cell activation one triggered by the antigen recognition and another produced by a co-stimulatory molecule, such as CD28/B7, which promotes the IL-2 synthesis to complete the activation of T-cells and avoid apoptosis.

Third-generation CARs combine sequences of co-stimulatory signals, such as OX40 (CD134), CD28, 4-1BB (CD137), CD27, DAP10, or other molecules, in combination with CD3ζ. The combination of multiple co-stimulatory signals may enhance CAR T-cell function via increased cytokine production, T-cell proliferation, and killing in the setting of recursive exposure to antigen.

Fourth Generation CARs Additionally, further optimized design of CARs, such as CAR T-cells redirected for universal cytokine killing (TRUCK), has also been suggested by many researchers. TRUCK cells produce and then release a transgenic product, such as IL-12 or IFN-γ.

Advantages of CAR-T cells includes HLA (Human Leukocyte Antigen) independent antigen recognition, Minimal risk of generating undesired autoimmunity or GvHD (Graft-versus-host disease), Significant quantities of tumor-specific T-cells are rapidly generated, CARs active in both CD4 + and CD8 + T-cells, Target antigens include proteins, carbohydrates, and glycolipids.

One of the most challenging limitations of CAR-T cell therapy is the development of tumor resistance to single antigen targeting CAR constructs. Although initially single antigen targeting CAR-T cells can deliver high response rates, the malignant cells of a significant portion of patients treated with these CAR-T cells display either partial or complete loss of target antigen expression. One of the challenges in targeting solid tumor antigens is that solid tumor antigens are often also expressed on normal tissues at varying levels. Compared to hematological malignancies, solid tumor CAR-T cell therapy is limited by the ability of CAR-T cells to traffic to and infiltrate solid tumors as the immunosuppressive tumor microenvironment and physical tumor barriers such as the tumor stroma limit the penetration and mobility of CAR-T cells.

"Chimeric Antigen Receptor T-Cell Therapy (CAR-T) - Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Chimeric Antigen Receptor T-Cell Therapy (CAR-T) pipeline landscape is provided which includes the disease overview and Chimeric Antigen Receptor T-Cell Therapy (CAR-T) treatment guidelines. The assessment part of the report embraces, in depth Chimeric Antigen Receptor T-Cell Therapy (CAR-T) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Chimeric Antigen Receptor T-Cell Therapy (CAR-T) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Chimeric Antigen Receptor T-Cell Therapy (CAR-T) R&D. The therapies under development are focused on novel approaches to treat/improve Chimeric Antigen Receptor T-Cell Therapy (CAR-T).

Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Emerging Drugs Chapters

This segment of the Chimeric Antigen Receptor T-Cell Therapy (CAR-T) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Emerging Drugs

• Descartes-08: Cartesian Therapeutics

Descartes-08 is an mRNA-modified, autologous CAR T-cell product directed against B-Cell Maturation Antigen (BCMA) that utilizes a novel modality and mechanism of action for treating gMG and other autoimmune diseases. Descartes-08 differs from anti-B-cell agents, which do not address long-lived plasma cells, and differs from FcRn blockers or complement inhibitors, which attempt to intervene only after autoantibodies are produced and pathogenic mediators are amplified. Descartes-08 is intended to halt production of autoantibodies by targeting pathogenic long-lived plasma cells with the potential to survive for decades within the body. Currently, the drug is in the Phase II stage of its development for the treatment of Myasthenia gravis (gMG).

• CART-ddBCMA: Arcellx, Inc

CART-ddBCMA is a genetically modified cell therapy utilizing a novel synthetic binding domain that is computationally designed, highly stable, and engineered to reduce immunogenicity. CART-ddBCMA is a Phase I study of Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed and refractory multiple myeloma. The Arcellx ddBCMA cell therapy has been granted Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration. The Phase I study is currently enrolling patients. CART-ddBCMA was well tolerated and rapid, deep, and durable responses were observed at the first dose level of 100 million cells, with six of six evaluable patients responding per IMWG criteria. Currently, the drug is in the Phase II stage of its development for the treatment of Multiple myeloma.

• NXC-201: Nexcella, Inc

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. NXC-201 (formerly HBI0101) is the only “Single-Day CRS” CAR-T cell therapy that is uniquely suited to target AL Amyloidosis and other autoimmune diseases. It is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, and expanding into other autoimmune indications. These trials build on a robust NXC-201 clinical dataset initiated in February 2021. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and awarded EU ODD by the EMA in AL Amyloidosis. Currently, the drug is in the Phase I/II stage of its development for the treatment of AL Amyloidosis and multiple myeloma.

• AUTO-8: Autolus Therapeutics

AUTO8 is the next-generation product candidate for multiple myeloma which comprises two independent CARs for the multiple myeloma targets, BCMA and CD19. The company have developed an optimized BCMA CAR which is designed for improved killing of target cell that express BCMA at low levels. This has been combined with fast off rate CD19 CAR from obe-cel the company believes that the design of AUTO8 has the potential to induce deep and durable responses and extend the durability of effect over other BCMA CARs currently in development. Currently, the drug is in the Phase I stage of its development for the treatment of multiple myeloma.

• SG299: Sana Biotechnology

SG299, is the first drug candidate from the fusogen platform, in generating CD19-directed CAR T cells with in vivo delivery. In 2023, look forward to initial clinical data for SC291, allogeneic CAR T cells for patients with B cell cancers; filing an IND for SC262, allogeneic CAR T cells for patients that have failed previous CAR T therapy and filing an IND for SG299, in vivo CAR delivery program for patients with B cell cancers. Currently, the drug is in the Preclinical stage of its development for the treatment of chronic lymphocytic leukemia.

Chimeric Antigen Receptor T-Cell Therapy (CAR-T): Therapeutic Assessment

This segment of the report provides insights about the different Chimeric Antigen Receptor T-Cell Therapy (CAR-T) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Chimeric Antigen Receptor T-Cell Therapy (CAR-T)

• There are approx. 180+ key companies which are developing the therapies for Chimeric Antigen Receptor T-Cell Therapy (CAR-T). The companies which have their Chimeric Antigen Receptor T-Cell Therapy (CAR-T) drug candidates in the most advanced stage, i.e. phase II include, Cartesian Therapeutics.

Phases

The report covers around 200+ products under different phases of clinical development like

• 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

Route of Administration

Chimeric Antigen Receptor T-Cell Therapy (CAR-T) 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

Molecule Type

Products have been categorized under various Molecule types such as

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

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Chimeric Antigen Receptor T-Cell Therapy (CAR-T): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chimeric Antigen Receptor T-Cell Therapy (CAR-T) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chimeric Antigen

Receptor T-Cell Therapy (CAR-T) drugs.

Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Report Insights

• Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Chimeric Antigen Receptor T-Cell Therapy (CAR-T) drugs?
• How many Chimeric Antigen Receptor T-Cell Therapy (CAR-T) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chimeric Antigen Receptor T-Cell Therapy (CAR-T)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chimeric Antigen Receptor T-Cell Therapy (CAR-T) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Chimeric Antigen Receptor T-Cell Therapy (CAR-T) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Cartesian Therapeutics
• Arcellx, Inc
• Nexcella, Inc
• Autolus Therapeutics
• Sana Biotechnology
• Orgenesis
• CARsgen
• TILT Biotherapeutics
• Poseida Therapeutics
• Precision BioSciences
• Novartis
• Kyverna Therapeutics
• Cemacabtagene ansegedleucel
• Hrain Biotechnology
• UTC Therapeutics
• Kiromic
• Suzhou Fundamenta Therapeutics
• Gracell Biotechnology
• CARsgen
• Innovent Biologics/Nanjing IASO Biotherapeutics
• CellabMED
• Umoja Biopharma
• TC BioPharm
• ElevateBio
• Century Therapeutics

Key Products

• Descartes-08
• CART-ddBCMA
• NXC-201
• AUTO-8
• SG299
• ORGCAR 19.22
• KJ-C2113
• TILT-123
• P-MUC1C-ALLO1
• PBCAR-0191
• CTL 119
• KYV 101
• Allogene Therapeutics
• HR 001
• Autologous chimeric antigen receptor T cell therapy
• Gamma delta chimeric antigen receptor T-cell therapy
• ThisCART 19 A
• AZD 0120
• CT 071
• Equecabtagene autoleucel
• CLM 202
• UB VV310
• CAR-T cell therapy
• Research programme: CAR-T cell therapies
• CNTY 108

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