Part of NATIONAL INSTITUTES OF HEALTH
Clinical Trials
3
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1937
Completed
1
33.3%
Not yet recruiting
2
66.7%
No approval data available
- A new Landmark Perspective in Science marks the 50th anniversary of Robert C. Gallo's 1976 discovery of a human T-cell growth factor later named interleukin-2 (IL-2). - The discovery enabled long-term culture of human T cells, leading to identification of the first human retroviruses HTLV-1 and HTLV-2 and establishing human retrovirology. - The same capability proved critical to characterizing HIV as the cause of AIDS and to developing the HIV blood test, improving global blood supply safety. - IL-2 also underpinned cellular immunotherapy advances including tumor-infiltrating lymphocyte therapy and CAR-T cell therapy, with scientific exchange continuing in Venice in 2027.
- Medicare's MolDX program, administered by Palmetto GBA, has proposed ending coverage for DCIS biomarker tests including DCISionRT, citing insufficient evidence versus existing clinicopathologic tools. - A 2024 study of 2,007 women across 63 sites found physician radiation recommendations changed in 38% of cases after DCISionRT results, moving decisions in both directions. - A head-to-head analysis of 926 patients found women reclassified as high-risk by the test had a 10-year recurrence rate of 21.4% without radiation versus 6.4% with it. - The dispute could shape future Medicare coverage of precision-medicine diagnostics, with concerns raised about a potential two-tier system for older versus commercially insured patients.
- Weill Cornell Medicine researchers found that propionyl-CoA, a byproduct of isoleucine and valine breakdown, switches on cholesterol production in prostate cancer cells. - The metabolite propionylates and stabilizes SREBP2, keeping cholesterol-producing genes active even when cholesterol levels should suppress them. - Restricting isoleucine and valine slowed tumor growth and reduced lung metastases in mouse models, while boosting propionyl-CoA had the opposite effect. - Investigators suggest enzyme inhibitors or controlled dietary amino acid restriction could be combined with enzalutamide to limit androgen receptor therapy resistance.
- Johns Hopkins Medicine researchers identified N4-acetylcytidine (ac4C), a naturally occurring RNA modification, as a potential way to make mRNA therapies produce more protein inside cells. - Ribosomes traveled nearly twice as fast on ac4C-modified mRNA compared with the industry-standard N1-methylpseudouridine (m1Ψ) platform, preventing ribosomal "traffic jams." - The ac4C platform produced more and better proteins, suggesting future mRNA drugs could achieve therapeutic effects with smaller doses. - The findings, published in Nature and co-led by the NIH, could influence vaccines and treatments for cancer, infectious diseases, and autoimmune conditions.
- A JAMA Oncology analysis of 11,681 US cancer trials (2008–2024) found industry sponsored 81.9% of studies, while federally funded trials disproportionately addressed rare, pediatric, and multimodality research questions. - Federally sponsored trials more often investigated dose de-escalation, non-drug interventions, and combination regimens, whereas industry trials favored single-agent treatments and phase I/III designs. - A separate evaluation of 1,378 federally sponsored trials showed median drug costs exceeded $7.5 million, rising to $11.08 million for federally led studies and nearly $60 million for phase 3 trials. - Researchers warn that reliance on industry for drug supply may limit the types of questions federally funded investigators can ask, underscoring the need for policy innovations to reduce costs.
- Monomethyl auristatin E (MMAE), a potent chemotherapy payload used in antibody-drug conjugates, causes peripheral neuropathy in roughly 50% of treated patients, sometimes requiring dose reduction or treatment discontinuation. - University at Buffalo researchers received more than $410,000 from the National Cancer Institute to investigate why MMAE causes nerve damage and how it might be prevented. - The two-year study will examine whether modulating permeability glycoprotein (P-gp) can reduce neurotoxicity, using animal models that mimic human genetic deficiencies and drug interactions. - Findings could enable new or repurposed drugs to prevent neuropathy, allowing patients to maintain full dosages and avoid long-term quality-of-life impairment.
- VCU Massey Comprehensive Cancer Center received a $2.7 million Worta McCaskill-Stevens K12 grant from the National Institutes of Health spanning five years. - The grant will train six early-stage clinician scientists in designing and conducting cancer prevention and control clinical trials, addressing a critical gap in formal clinical trial training. - Massey is one of only two NCI-designated comprehensive cancer centers nationwide to secure this competitive career development award. - Scholars will be guided by a unique triad mentoring model pairing a cancer prevention investigator, an experienced clinical trialist, and a community champion.
- Rowan University researchers are using 3D bioprinting to construct living tumor models of chondrosarcoma, a bone cancer resistant to chemotherapy, radiation, and most systemic treatments. - The two-year National Cancer Institute-funded project places tumor cells and mesenchymal stem cells at controlled distances within a hydrogel to study their interaction over 30 days. - The team hypothesizes that chondrosarcoma cells reprogram recruited stem cells into "accomplices" that release tissue-degrading enzymes, facilitating tumor invasion into surrounding tissue. - Molecular analyses, including single-cell RNA sequencing, aim to identify the signaling events driving this cellular reprogramming, potentially revealing new therapeutic targets.
- The NCI-led Human Cancer Model Initiative published 665 validated patient-derived organoid models covering 25 cancer types in Nature, doubling the number of in vitro models available globally. - The CSHL-Northwell Health consortium contributed over 150 organoid models, including rare and underrepresented cancer subtypes such as endometrial and pediatric cancers. - Each model is annotated with comprehensive clinical data, treatment history, and advanced molecular profiles including DNA/RNA sequencing and epigenetic data. - The resource has already expanded the Cancer Dependency Map, enabling CRISPR-based discovery of new therapeutic vulnerabilities across diverse cancer subtypes.
- The Alliance for Clinical Trials in Oncology has activated the QUANTUM Trial (Alliance A062401), a Phase II study testing the bispecific antibody teclistamab as post-transplant consolidation in newly diagnosed primary plasma cell leukemia. - Primary plasma cell leukemia is a rare and aggressive blood cancer with approximately 1,200 new U.S. cases annually, and long-term survival remains poor despite intensive modern therapy. - The trial will randomize 74 adults after autologous stem cell transplant to receive either teclistamab consolidation or continued D-KRd quadruplet therapy, with overall survival as the key endpoint. - Teclistamab, already FDA-approved for certain multiple myeloma patients, is a BCMA×CD3 bispecific antibody that redirects T cells to attack malignant plasma cells, and this study will determine whether earlier use can improve long-term outcomes.
