RecruitingPhase 1NCT07246707

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

Sponsor

Zhejiang University

Enrollment

30 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

B-ALL

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests KSV01, a new CAR-T cell therapy (engineered immune cells designed to fight cancer), in adults with relapsed or treatment-resistant B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer that has come back or stopped responding to prior treatments. **You may be eligible if...** - You are 18 to 80 years old with a confirmed diagnosis of B-cell ALL - Your cancer has come back or stopped responding to previous treatments - You are in reasonably good health (ECOG performance status 0 or 1) - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You have active, uncontrolled infections (including HIV, hepatitis B/C) - You have had prior CD19-targeted CAR-T therapy (or meet specific exclusions for your CAR-T history) - You have significant heart, liver, or kidney dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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