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PIONEER-CAR-T-01
This Phase I first-in-human clinical trial evaluates the safety, tolerability, and preliminary efficacy of KITE-9876, an autologous CAR T-cell therapy, in adults with relapsed or refractory B-cell non-Hodgkin lymphoma who have limited treatment options. The study will enroll 60 patients aged 18-65 with confirmed B-cell NHL subtypes, using a dose-escalation design with four planned dose levels.
STUDY TIMELINE
STUDY OBJECTIVES
- To evaluate the safety and tolerability of KITE-9876 and identify dose-limiting toxicities (DLTs) - To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
- To assess preliminary antitumor activity using overall response rate (ORR) per Lugano 2014 criteria - To characterize CAR T-cell expansion, persistence, and phenotype in peripheral blood
- To measure changes in serum cytokines and inflammatory markers
STUDY POPULATION
Histologically confirmed B-cell non-Hodgkin lymphoma (DLBCL, FL Grade 3B, MCL, or other aggressive subtypes), relapsed or refractory after ≥2 prior therapies including anti-CD20 antibody and anthracycline
STUDY INTERVENTIONS
SAFETY MONITORING
**Interim Analysis Planned** Yes - safety review after each cohort before dose escalation **Special Safety Monitoring** - ≥ Neurological assessments (ICE score, neurologic exam) every 8 hours Days 0-7, then daily through Day 14 - ≥ Cardiac monitoring (continuous telemetry Days 0-7 for patients with cardiac risk factors)
The Four Foundations
Named after the daughters of Asclepius, each module brings divine precision to clinical trial protocol development.
In Greek mythology, Panacea was the goddess of universal remedy—the cure-all. Her four siblings each represented a different aspect of healing: Aglaea (beauty & splendor), Hygeia (prevention), Iaso (recuperation), and Aceso (healing). Together, they formed complete healthcare. Panaceon AI embodies this philosophy—four essential tools that work together to create complete protocol excellence.
AGLAEA
AI-powered protocol generation that creates FDA-ready drafts 30-40% faster. Aglaea, the Greek goddess of beauty and splendor, brings elegance and precision to every section of your clinical trial protocol.
HYGEIA
Automated regulatory compliance analysis powered by AI. Hygeia, the Greek goddess of health and hygiene, ensures your protocols meet FDA, EMA, and ICH-GCP standards with 97% accuracy.
IASO
AI identifies ripple effects and predicts downstream impacts of protocol amendments. Iaso, the Greek goddess of recovery, helps you manage changes without losing control.
ACESO
Semantic search across 500K+ clinical trials, FDA guidance, EMA guidelines, and scientific literature. Aceso, the Greek goddess of healing, brings knowledge to your fingertips.
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