CAR-T Immunotherapy Clinical Trial: Jichi Medical University
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
Phase I/II Trial Overview
- January 8, 2016
Jichi Medical University initiated CAR-T cell immunotherapy clinical trial targeting relapsed/refractory CD19+ B-cell non-Hodgkin's lymphoma. CAR-T cell engineering involves genetic modification of patient immune cells to enhance anti-tumor cytotoxicity.
Patient Selection Criteria
Age Range: 20-70 years (current recruitment)
Inclusion Criteria:
- Relapsed or refractory CD19+ B-cell NHL
- Imaging-confirmed disease with PET-positive lesions
- ECOG performance status 0-2
- Adequate hematologic/hepatic/renal function:
- Neutrophils ≥1,500/μL
- Platelets ≥10 × 10⁴/μL
- Total bilirubin ≤2.0 mg/dL
- AST/ALT ≤150 IU/dL
- ALP ≤1.5× upper limit of normal
- Creatinine ≤2.0 mg/dL
- SpO2 ≥92% (room air)
- Life expectancy ≥3 months
- Written informed consent
Target Enrollment: 18 patients
Safety Monitoring
CAR-T immunotherapy requires careful adverse event monitoring. Clinical trial represents investigational approach without efficacy guarantees. Full understanding of risks essential before enrollment.
Pediatric Expansion Phase
Future expansion planned for pediatric cohort (ages 1-15 years) to validate CAR-T safety across broader developmental range.
Study Institution
Jichi Medical University Address: 3311-1 Yakushiji, Shimono, Tochigi Prefecture, Japan Contact: 0285-58-7353
Data Source
Jichi Medical University CAR-T Immunotherapy Program
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