Clinical Trials
162
17 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1826
Active, not recruiting
8
4.9%
Completed
118
72.8%
Enrolling By Invitation
1
0.6%
Not yet recruiting
8
4.9%
Recruiting
21
13.0%
Terminated
5
3.1%
Withdrawn
1
0.6%
No approval data available
- Scientists from Celloram Inc., University Hospitals, and Case Western Reserve University have developed PROTEXI, a dendritic cell vaccine platform that repurposes SARS-CoV-2 immune memory to fight cancer, published in Nature Communications. - PROTEXI pairs tumor-specific antigens with SARS-CoV-2 Spike protein epitopes to convert pre-existing antiviral CD4⁺ helper T-cell immunity into a catalyst for antitumor CD8⁺ cytotoxic T-cell responses. - In preclinical models of melanoma and breast cancer, PROTEXI slowed tumor growth, improved survival, reshaped the tumor microenvironment, and demonstrated efficacy in humanized mouse models using cells from COVID-19-vaccinated donors. - Celloram and University Hospitals are advancing PROTEXI toward a first-in-human clinical trial in patients with sarcoma, evaluating safety, feasibility, and immunologic activity of this personalized vaccine approach.
- Researchers at University Hospitals and Case Western Reserve University have identified KLF4, a protein produced by blood-brain barrier endothelial cells, as a critical factor in age-related cognitive decline. - Loss of endothelial KLF4 accelerated blood-brain barrier degradation, reduced brain blood vessels, and led to oxidative damage, neuroinflammation, and cognitive impairment in mouse models. - Single-cell RNA sequencing revealed disrupted immune response and barrier integrity pathways, explaining KLF4's broad effects on brain health during aging. - The findings suggest that therapies preserving or restoring KLF4 function may help prevent age-related blood-brain barrier deterioration and associated cognitive decline.
- Inhibition of the enzyme 15-PGDH restored redox homeostasis and protected against neuroinflammation, neuronal cell death, and motor impairment in three mouse models of Parkinson's disease. - Both human PD brain tissue and mouse models showed abnormally elevated levels of 15-PGDH, with neuroprotection achieved independently of changes in α-synuclein pathology. - The 15-PGDH inhibitor MF-300 has already completed Phase 1 clinical trials with no observed toxicity, supporting the rationale for repurposing existing agents for PD treatment. - The research, published in Redox Biology, builds on prior award-winning work and identifies a downstream trio of mediators—Lcn2, IL-1β, and Cybb/Nox2—as key mechanistic targets.
- Whitehawk Therapeutics presented real-world analysis at ASCO 2026 demonstrating that SEZ6 expression in small cell lung cancer exceeds approved and emerging ADC targets by at least 3-fold compared to HER2, B7-H3, DLL3, PD-L1 and PD-1. - The analysis revealed SEZ6 expression is highest in SCLC-A and SCLC-N molecular subtypes, which account for approximately 90% of all SCLC cases and are characterized by high neuroendocrine transcription factor expression. - SEZ6 expression positively correlates with DLL3 across neuroendocrine carcinomas, indicating potential for combination therapy approaches with existing DLL3-targeted treatments. - The company plans to submit an Investigational New Drug application for its biparatopic SEZ6-directed ADC HWK-206 in mid-2026, with Phase 1 trials expected to begin in Q3 2026.
- Caring Cross's first-in-human Phase I/IIa trial of anti-HIV duoCAR-T cell therapy demonstrated sustained viral control in two participants for nearly one and two years respectively after stopping antiretroviral therapy. - The therapy showed particular promise in patients who initiated HIV treatment early in their infection, with no serious adverse events attributed to the CAR-T cell product itself. - Nine participants received the single-dose treatment using their own genetically engineered T cells, with conditioning regimens proving crucial for therapeutic efficacy. - The results suggest a potential pathway toward a functional HIV cure that could eliminate the need for lifelong antiretroviral therapy in select patients.
- Researchers at Case Western Reserve University developed OSM CAR-T therapy that successfully attacks osteosarcoma tumors in mouse models by targeting Oncostatin M protein receptors. - The therapy showed anti-tumor effects against all osteosarcoma patient samples tested and effectively killed metastatic tumor cells in mouse models. - Clinical trials are anticipated within two years, potentially offering the first major treatment advance for osteosarcoma in 40 years. - The approach could reduce surgery needs and provide hope for patients with metastatic disease who are typically non-responsive to existing therapies.
- The FDA has granted Breakthrough Device Designation to Hemex Health's Gazelle® Hb Variant Test, recognizing its potential to address unmet needs in sickle cell disease monitoring. - The Gazelle platform uses miniaturized electrophoresis technology to rapidly separate and detect hemoglobin fractions and variants, enabling decentralized access to quantitative hemoglobin data. - Through the Breakthrough Devices Program, Hemex will receive prioritized FDA interaction and feedback to expedite development of this point-of-care diagnostic solution. - The designation reflects FDA recognition of the need for improved tools to support sickle cell disease management, though it does not guarantee regulatory clearance.
- A comprehensive meta-analysis of 10,266 patients from 13 randomized phase III trials found that longer durations of androgen-deprivation therapy with radiotherapy provide nonlinear survival benefits in localized prostate cancer. - The study revealed that 3-month and 9-month androgen-deprivation therapy durations showed significantly poorer overall survival compared to 36-month treatment, while 18-month therapy showed no significant difference. - Optimal therapy durations varied by risk category, with 0, 6, and 12 months recommended for patients with one intermediate-risk factor, multiple intermediate-risk factors, and high-risk disease, respectively. - Extended androgen-deprivation therapy beyond 9-12 months showed diminishing returns for cancer-specific benefits while increasing risk of non-cancer mortality.
- Researchers from University Hospitals and Case Western Reserve University successfully reversed advanced Alzheimer's disease in two different mouse models by restoring brain NAD+ levels using compound P7C3-A20. - The study demonstrated that maintaining proper NAD+ balance not only prevented Alzheimer's development but also enabled complete cognitive recovery even after significant disease progression had occurred. - Both mouse models showed normalized blood levels of phosphorylated tau 217, a clinical biomarker of Alzheimer's, providing strong evidence of disease reversal and potential for future human trials. - The findings challenge the century-old belief that Alzheimer's is irreversible and suggest therapeutic strategies targeting brain energy balance could offer a path to disease recovery rather than just prevention or slowing.
- NervGen Pharma announced a $10 million private placement to advance NVG-291, a first-in-class therapeutic peptide targeting nervous system repair for spinal cord injury. - The financing includes participation from SCI Ventures, the world's first specialist venture fund focused on paralysis, and will support the company's anticipated Nasdaq listing. - NVG-291 has received FDA Fast Track designation and EMA Orphan Designation, with ongoing Phase 1b/2a clinical trials in spinal cord injury patients. - The therapy targets a significant unmet need, as spinal cord injury impacts over 20 million people globally with lifetime care costs exceeding $6 million per patient in the U.S.
