NCT07246707

KSV01 Injection as the Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 injection for patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).

Detailed description

This investigator-initiated clinical study aims to evaluate KSV01 injection, the third-generation self-inactivating lentiviral vector that carries CD19 CAR, in patients with r/r B-ALL. The study employs a BOIN design to assess safety, tolerability, and preliminary efficacy.

Conditions

• B-ALL

Interventions

Type	Name	Description
DRUG	KSV01 Injection	KSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector.

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-10-01
• Completion: 2028-06-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: China