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Clinical Trial News

Novoxel and GPOphtho Partner to Expand Access to FDA-Cleared Tixel Device for Dry Eye Treatment Across US

  • Novoxel Inc. and GPOphtho have finalized a strategic agreement to expand access to the Tixel device family for treating dry eye and aesthetic procedures nationwide.
  • The Tixel i device specifically targets Meibomian Gland Dysfunction (MGD) with a 2-minute treatment for both eyes, supported by recent clinical trial data showing safety and efficacy.
  • The FDA-cleared device uses proprietary Thermo-Mechanical Action technology to provide non-invasive treatments without needles, bleeding, or radiation exposure.
  • The partnership enables eyecare physicians to integrate both functional dry eye treatments and cosmetic procedures, creating new revenue streams through discounted pricing packages.

Nxera Pharma Achieves Key Development Milestone in Eli Lilly Collaboration for Diabetes and Metabolic Disease Treatments

Drug Discovery
  • Nxera Pharma has achieved a significant development milestone in its multi-target collaboration with Eli Lilly targeting diabetes and metabolic diseases, triggering an undisclosed milestone payment.
  • The milestone validates Nxera's NxWave™ platform for identifying small molecule binders to GPCR targets and solving receptor structures to reveal binding sites.
  • Under the collaboration agreement established in 2022, Nxera is eligible to receive up to $694 million in development and commercial milestones plus tiered royalties on global sales.
  • Lilly will now assume responsibility for further development and commercialization of the compounds identified through Nxera's proprietary drug discovery platform.

MHRA Grants Conditional Approval for CAR-T Therapy Aucatzyl to Treat Relapsed B-Cell ALL

CAR-TDrug Approval
  • The MHRA granted conditional marketing authorization for obecabtagene autoleucel (Aucatzyl), a CAR-T cell therapy for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia on April 25, 2025.
  • The European Medicines Agency's CHMP adopted a positive opinion for Aucatzyl on May 22, 2025, recommending conditional approval for adults aged 26 years and older with the same indication.
  • B-cell precursor ALL is a blood cancer affecting white blood cells where bone marrow produces abnormal, immature B-lymphocytes that grow and divide rapidly.
  • This approval represents a significant advancement in CAR-T cell therapy for treating this aggressive form of blood cancer in patients who have failed previous treatments.

Mirvie's RNA Blood Test Predicts Preeclampsia Risk Months Before Symptoms in Major Study

Precision Medicine
  • Mirvie's blood test successfully identified 91% of preterm preeclampsia cases in women over 35 without pre-existing conditions, using RNA signatures detectable at 17.5-22 weeks gestation.
  • The study analyzed over 9,000 pregnancies and discovered molecular signatures that distinguish between severe and mild hypertensive disorders of pregnancy for the first time.
  • Preeclampsia rates have nearly doubled in the past decade, now affecting 1 in 12 pregnancies, highlighting the urgent need for better predictive tools.
  • The clinically validated test will be available under the Encompass brand, enabling proactive care plans including low-dose aspirin therapy months before symptoms appear.

Real-World Data Confirms Low-Severity Safety Profile for Lisocabtagene Maraleucel Across Blood Cancer Settings

CAR-TReal World Evidence
  • Real-world data from 877 patients and clinical trial data from 702 patients demonstrate that most cytokine release syndrome and neurological events with lisocabtagene maraleucel occur within 15 days of infusion and are not severe.
  • Among patients experiencing late-onset adverse events after day 15, the vast majority were grade 1/2 events that resolved without requiring intensive care unit-level management.
  • The findings support optimized monitoring strategies that could improve patient access to CAR-T therapy while maintaining safety standards across multiple blood cancer indications.

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT03331198RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/27/2017

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

NCT03483103CompletedPhase 2
Juno Therapeutics, a Subsidiary of Celgene
Posted 7/27/2018

Sintilimab/Chidamide Combination Shows Promising Results in Early-Stage Natural Killer T-Cell Lymphoma

  • The phase 2 SCENT-2 trial demonstrated that sintilimab plus chidamide followed by P-GemOx achieved a 95.7% objective response rate with 93.6% complete response in 47 patients with treatment-naïve early-stage ENKTL.
  • At 17 months median follow-up, the combination showed excellent survival outcomes with 1-year progression-free survival of 95.7% and overall survival of 95.3%.
  • The treatment regimen demonstrated manageable toxicity profile, with most adverse effects attributed to the P-GemOx chemotherapy component rather than the immunotherapy combination.
  • Results suggest this novel chemotherapy-reduced approach may serve as an effective induction regimen for treatment-naïve patients with early-stage extranodal natural killer T-cell lymphoma.

Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL

NCT03820596CompletedPhase 1
Huiqiang Huang
Posted 3/29/2019

Sintilimab in Combination With Chidamide in Newly Diagnosed ENKTCL

NCT04994210RecruitingPhase 2
Sun Yat-sen University
Posted 10/4/2021

Anti-Inflammatory Diet Reduces Death Risk by 87% in Stage III Colon Cancer Patients

  • Patients with stage III colon cancer consuming the most pro-inflammatory diets had an 87% higher risk of death compared to those with the least inflammatory diets in a phase 3 clinical trial analysis.
  • The study analyzed 1,625 patients from the CALGB/SWOG 80702 trial using empirical dietary inflammatory pattern (EDIP) scores to assess dietary inflammation levels.
  • Combining anti-inflammatory diets with higher physical activity levels provided the greatest survival benefit, reducing death risk by 63% compared to patients with pro-inflammatory diets and low activity.
  • The protective effect of anti-inflammatory diets remained consistent regardless of whether patients received the anti-inflammatory drug celecoxib during treatment.

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

NCT01150045Unknown StatusPhase 3
Alliance for Clinical Trials in Oncology
Posted 6/1/2010

Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer

NCT00819208Active, Not RecruitingNot Applicable
Canadian Cancer Trials Group
Posted 6/2/2009

Real-World Data Shows Yescarta CAR-T Therapy Safe and Effective in Outpatient Setting

CAR-TReal World Evidence
  • Kite presented real-world data from 238 patients showing comparable safety and effectiveness outcomes for Yescarta CAR-T therapy administered in outpatient versus inpatient settings for relapsed/refractory large B-cell lymphoma.
  • The analysis found no significant differences in rates of cytokine release syndrome, neurologic events, or immune effector cell-associated neurotoxicity syndrome grade ≥3 between treatment settings.
  • Nearly 25% of outpatient-assigned patients avoided hospital admission within 30 days, and 50% avoided admission within 3 days, demonstrating potential cost-effective advantages.
  • The study supports expanding access to this potentially curative one-time treatment while reducing healthcare system burden and improving patient convenience.

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

Gilead's Dual-Target CAR-T Therapy Achieves 62% Response Rate in Recurrent Glioblastoma

CAR-TOncology
  • Gilead Sciences' dual-target CAR-T therapy shrank tumors in 62% of patients with recurrent glioblastoma, a rare achievement for this fatal brain cancer.
  • The experimental treatment targets both EGFR and interleukin-13 receptor alpha 2, injected directly into spinal fluid to overcome glioblastoma's multiple tumor cell populations.
  • While responses were encouraging, benefits proved largely temporary with many patients relapsing within two to three months after treatment.
  • Kite is developing a triple-target version to improve persistence and plans to test the therapy in newly diagnosed patients next year.

Dual-Target CAR T Cell Therapy Achieves Tumor Shrinkage in 62% of Recurrent Glioblastoma Patients

CAR-T
  • A novel dual-target CAR T cell therapy targeting EGFR and IL13Rα2 proteins achieved tumor shrinkage in 62% of patients with recurrent glioblastoma, the most aggressive form of brain cancer.
  • The experimental treatment delivered directly into cerebrospinal fluid showed encouraging survival signals, with 43% of patients surviving beyond 12 months compared to typical 6-10 month survival rates.
  • Penn researchers established the therapy's safety profile and maximum tolerated dose, paving the way for upcoming clinical trials in newly diagnosed glioblastoma patients.

CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy

NCT06973096RecruitingPhase 1
University of Pennsylvania
Posted 7/18/2025

A Study Evaluating Temferon in Patients with Glioblastoma & Unmethylated MGMT

NCT03866109RecruitingPhase 1
Genenta Science
Posted 3/5/2019

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