NCT06367114

Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)

Phase Ⅱ Clinical Trial of ssCART-19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration.

Detailed description

This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period. All subjects who have received ssCART-19 infusion will be followed for safety and efficacy up to 2 years.

Conditions

• Relapsed or Refractory Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	ssCART-19	Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.
DRUG	Fludarabine	Fludarabine is used for lymphodepletion.
DRUG	Cyclophosphamide	Cyclophosphamide is used for lymphodepletion.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-09-01
• Completion: 2025-12-01
• First posted: 2024-04-16
• Last updated: 2024-04-19

Locations

2 sites across 1 country: China