NCT06314828

A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL

A Phase 1, Open-label, Single Arm Clinical Trial to Evaluate the Tolerability, Safety and Efficacy of RJMty19 in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Guangdong Ruishun Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, single-arm study to evaluate tolerability, safety and efficacy of RJMty19 in adult subjects with r/r B-NHL.

Detailed description

The study was based on an accelerated titration and "3+3" design with a dose-escalation phase and a dose-expansion phase, and was designed to assess the safety, maximum tolerated dose, pharmacokinetic profile, and initial efficacy of RJMty19 in subjects with r/r B-NHL after second-line treatment or above.

Conditions

• B-cell Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	RJMty19 (CD19-CAR-DNT cells)	Lentiviral vector-transducted double negative T cells (DNT) to express anti-CD19 CAR. Prior to cellular infusion, each patient received cyclophosphamide, fludarabine and Etoposide lymphodepleting chemotherapy.

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-05-20
• Completion: 2027-05-20
• First posted: 2024-03-18
• Last updated: 2024-03-18