NCT06364852

An Evaluation of LY007 Cell Injection for r/r B-NHL

An Evaluation of LY007 Cell Injection for Recurrent/Refractory CD20 Was Positive Tolerability, Safety, and Efficacy of B-cell Non-Hodgkin Lymphoma in Open, Single-arm Stage I Clinical Research

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research

Detailed description

This is a phase I single-arm, open, "3+3" dose escalation study to evaluate the efficacy of LY007 cell injection Safety, tolerability, PK characteristics, PD characteristics, initial efficacy and immunogenicity. This study plans to enroll approximately 9-18 subjects with relapsed/refractory CD20-positive B-NHL, including DLBCL (inclusive Histological transformation) and TFL. The number of subjects ultimately enrolled depends on the number of DLT observed during the dose escalation phase The number of incremental dose groups prior to DLT and the determination of MTD or clinically recommended dose.

Conditions

• B-NHL

Interventions

Type	Name	Description
DRUG	LY007	FC and LY007 infusion

Timeline

• Start date: 2021-12-25
• Primary completion: 2024-08-31
• Completion: 2026-05-31
• First posted: 2024-04-15
• Last updated: 2024-04-15

Locations

1 site across 1 country: China