相关临床试验
8
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2018
进行中（未招募）
1
12.5%
已完成
1
12.5%
招募中
3
37.5%
终止
3
37.5%
暂无批准数据
- Novartis paused trials of its CAR-T therapy rap-cel across lupus, myasthenia gravis, multiple sclerosis and other autoimmune indications after three cases of immune effector cell-associated hemophagocytic syndrome (IEC-HS). - Bristol Myers Squibb voluntarily paused enrollment in autoimmune trials of zola-cel after detecting transient and reversible inflammatory events during routine safety surveillance. - Both companies are reviewing clinical and safety data, with Novartis engaged with regulators and Bristol Myers aiming to resume testing as quickly as possible. - Analysts note the fast-manufacturing technology behind both therapies could be driving increased cell expansion and reported toxicities, warranting monitoring for future market adoption.
- A July 2026 survey of 92 neurologists found 77% believe CAR T therapies could make current standards of care obsolete in neuro-immune diseases if proven safe and effective. - Safety is the clearest adoption barrier, with 74% of neurologists citing the safety profile as a major concern, including cytokine release syndrome and neurotoxicity. - Cartesian Therapeutics' Descartes-08 (BCMA-directed) and Kyverna's miv-cel (anti-CD19) lead physician familiarity among investigational CAR T programs. - Neurologists expect initial delivery through academic centers and shared-care models with hematologist-oncologists, making logistics central to uptake.
- All 11 patients with refractory systemic sclerosis achieved rapid B-cell aplasia following dual-target CD19/BCMA CAR T-cell therapy, with significant improvements in skin thickness scores. - Modified Rodnan Skin Score improved from a baseline median of 19 to a median of 2 at month 6 (P < .001), and 73% of patients achieved low disease activity. - Lung involvement stabilized or improved, with 80% of patients showing regression of interstitial changes on high-resolution CT. - Researchers describe the immune "reset" strategy as having "curative potential," paving the way for phase 2 trials in this severe disease.
- Kyverna Therapeutics initiated a rolling BLA submission in May 2026 for miv-cel, a CAR T-cell therapy targeting Stiff Person Syndrome, following positive FDA feedback on a single-arm trial. - This milestone marks the first-ever regulatory filing for an autoimmune CAR T therapy, with a potential market launch anticipated in 2027. - The broader autoimmune neurological disorders market is projected to grow from USD 8.50 billion in 2025 to USD 17.79 billion by 2035, driven by targeted biologics and cell-based therapies. - Cell-based therapies represent the fastest-growing treatment segment in neuroimmunology, with a projected CAGR of 18.5% through 2035, reflecting a paradigm shift toward curative immune reprogramming.
- Kyverna Therapeutics has initiated a rolling Biologics License Application (BLA) for miv-cel, a CAR-T therapy targeting stiff person syndrome, following FDA acceptance of a single-arm trial design. - The company's 153-patient natural history study demonstrated that existing immunotherapies provide less than 20% improvement in mobility, contrasting with 100% immunotherapy-free rates achieved by miv-cel at 16 weeks. - If approved in 2027, miv-cel would become the first FDA-approved treatment for stiff person syndrome and the first CAR-T therapy for autoimmune diseases.
- Kyverna Therapeutics will announce topline results from its registrational Phase 2 KYSA-8 trial evaluating KYV-101 in stiff person syndrome on December 15, 2025. - KYV-101 is a fully human, autologous CD19 CAR T-cell therapy designed to achieve deep B-cell depletion and immune system reset with a single administration. - The company is advancing KYV-101 through late-stage clinical development with registrational trials for both stiff person syndrome and myasthenia gravis. - Kyverna's pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, with ongoing trials in multiple autoimmune conditions.
- DelveInsight's 2025 pipeline report reveals over 35 companies are actively developing more than 40 investigational therapies for lupus nephritis treatment. - Hoffmann-La Roche leads with obinutuzumab in Phase III trials, while other promising candidates include ADX-097 from Q32 Bio and NKX019 from Nkarta Therapeutics. - The FDA granted Fast Track designation to AlloNK from Artiva Biotherapeutics in February 2024 for combination therapy with rituximab or obinutuzumab. - Lupus nephritis affects patients with systemic lupus erythematosus and can progress to chronic kidney disease or end-stage renal disease without effective treatment.
- German physicians at Ruhr-University Bochum successfully treated two patients with chronic inflammatory demyelinating polyneuropathy (CIDP) using CAR-T cell therapy, achieving over 200% improvement in clinical scores and neurophysiological tests. - The treatment specifically targets pathogenic B-cells responsible for autoimmune attacks on the peripheral nervous system, with patients regaining mobility within days and requiring no further immune therapy after a single treatment. - Dutch researchers at LUMC became the first in the Netherlands to treat an autoimmune disease patient with CAR-T therapy, successfully eliminating autoantibodies in a neurological lupus case and enabling discontinuation of immunosuppressive treatment. - Both studies represent groundbreaking applications of cancer immunotherapy to severe autoimmune neurological conditions, offering new hope for treatment-resistant patients who have exhausted conventional therapeutic options.
- The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with estimates suggesting total industry funding could reach $281.7 billion when including undisclosed deals. - More than 170 companies worldwide are developing CAR-T products with 1,944 therapies in development, while 13 CAR-T cell therapies have received regulatory approval globally since 2017. - Despite a slowdown in IPOs and M&A activity in 2024, venture capital funding remains strong with 89 CAR-T companies securing $7.7 billion since 2014, supporting advancement in both blood cancer and solid tumor applications.
- The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. - Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. - Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.
