RecruitingEarly Phase 1NCT05651178

Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients

A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human CD19-CD22 Targeted T Cells Injection for Subjects with Central Nervous System Involvement of Refractory/Relapsed B Cell Malignancies

Sponsor

Hrain Biotechnology Co., Ltd.

Enrollment

10 participants

Start Date

Aug 12, 2022

Study Type

INTERVENTIONAL

Conditions

Central Nervous System Lymphoma

Summary

This study is a open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human CD19-CD22 Targeted T Cells by intravenous and intrathecal administration, and to preliminarily observe the efficacy of the trial drug in patients with central nervous system involvement of refractory/relapsed B cell malignancies.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a dual-targeted CAR T-cell therapy (targeting both CD19 and CD22 proteins) in patients with leukemia or lymphoma that has spread to the central nervous system (brain and spinal cord) and has not responded to other treatments. **You may be eligible if...** - You have been diagnosed with B-cell leukemia or lymphoma that has spread to the brain or spinal cord - Your cancer has come back after or did not respond to prior treatments - Your cancer cells test positive for CD19 or CD22 (or both) **You may NOT be eligible if...** - You have active serious infections - You have significant organ 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.

Interested in this trial?

Get notified about updates and connect with the research team.