CAR-T Immunotherapy Clinical Trial: Jichi Medical University

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:

1. Relapsed or refractory CD19+ B-cell NHL
2. Imaging-confirmed disease with PET-positive lesions
3. ECOG performance status 0-2
4. 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)
5. Life expectancy ≥3 months
6. 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

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

Figure 1

Figure 2

Figure 3

Figure 4