NCT06045585

JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma

Early Exploratory Clinical Study of the Safety, Tolerability and Initial Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Guangdong Second Provincial General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell lymphoma

Detailed description

This is a single-center, single-arm, open-treatment clinical study. In this study, approximately 10-20 adult and elderly patients with CD19-positive relapsed or refractory B-cell lymphoma will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of JY231 treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood, bone marrow, and cerebrospinal fluid were collected before and 12 months after the JY231 infusion to detection.

Conditions

• Relapsed or Refractory B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	infusion of JY231 injection	Infusion of JY231 Injection by dose of 1-10 x10\^6 TU/kg、 1-5 x10\^7 TU/kg、 5-10 x10\^7 TU/kg Administration method: intravenous infusion、intraperitoneally infusion、Lymph node infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion（PI evaluation is required）.

Timeline

• Start date: 2023-08-18
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: China