Expertise: Oncology & Hematology 84 results

Oncology & Hematology

What is Logic-Gating and Why Does It Matter in CAR-T Therapy? 

Chimeric antigen receptor T-cell (CAR-T) therapy has revolutionized the treatment landscape for certain hematological malignancies, offering hope where conventional therapies have been exhausted. By reprogramming a patient’s own T-cells to recognize and attack cancer cells, CAR-T therapy embodies the promise of personalized medicine. However, challenges such as severe immune-related toxicities, antigen escape, microenvironment suppression, and…

Oncology & Hematology

Mastering Dose Escalation Studies Part 2: Charting a Clear Path from Planning to Execution

Dose escalation studies are pivotal in the early phases of clinical drug development for evaluating the safety profile of a new therapeutic agent and identifying a recommended dose for further investigation. These studies lay the groundwork for understanding the pharmacokinetic and pharmacodynamic properties of novel therapies and, if designed and executed thoughtfully, can move seamlessly…

Oncology & Hematology

Mastering Dose Escalation Studies Part 1: Optimizing Efficiency in Phase I Trial Execution Using Adaptive Design

Adaptive design is a progressive approach that utilizes different statistical modeling to allow for modifications to enrollment in a clinical trial after study initiation without undermining data integrity and validity. This methodology is particularly beneficial and increasingly common in phase 1 clinical trials, which focus primarily on safety, tolerability, pharmacokinetics, and pharmacodynamics. The essence of…