RecruitingPhase 1NCT07260812

KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma


Sponsor

TCRx Therapeutics Co.Ltd

Enrollment

18 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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 diffuse large B-cell lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing KSV01 — a new CAR-T cell therapy where a patient's own immune cells are engineered in a lab to attack cancer — for people with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL), a type of blood cancer that has come back or stopped responding to treatment. **You may be eligible if...** - You are between 18 and 80 years old - You have confirmed B-cell NHL that has returned or is not responding to treatment - You are in reasonably good physical condition (ECOG score 0–1, KPS ≥70) - Your life expectancy is more than 3 months - You have adequate organ function based on blood tests **You may NOT be eligible if...** - You have active brain involvement from lymphoma - You have serious autoimmune disease or uncontrolled infections - You have had certain prior CAR-T or gene therapy treatments - Your heart, liver, or kidney function is too poor to safely receive the treatment 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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Interventions

DRUGKSV01 Injection

KSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries CD19 CAR.


Locations(1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

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NCT07260812


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