RecruitingPhase 1Phase 2NCT05768529

Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Single-arm, Open and Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of U16 Injection in the Treatment of Refractory/Recurrent B-cell Non-Hodgkin's Lymphoma (r/r B-NHL)


Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Enrollment

100 participants

Start Date

Mar 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study is a Phase I/II, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called U16 in patients with B-cell non-Hodgkin's lymphoma that has come back or stopped responding to at least two prior treatments. U16 targets CD20, a protein on the surface of cancer cells. **You may be eligible if...** - You are between 18 and 70 years old - You have CD20-positive B-cell non-Hodgkin's lymphoma (including diffuse large B-cell lymphoma and related subtypes), confirmed by tissue testing - You have already received at least 2 prior lines of treatment, including chemotherapy containing anthracyclines, and CD20-targeting therapy - You have measurable disease on scans **You may NOT be eligible if...** - You have not had at least 2 prior lines of treatment - Your lymphoma is not CD20-positive - You are in poor overall health 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

DRUGU16

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered before U16 treatment.


Locations(2)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT05768529