RecruitingPhase 1NCT07093073

Clinical Study of U01(ssCART-19) in Patients With B-Cell Lymphoma

A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma.


Sponsor

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

Enrollment

30 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label clinical study evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.


Eligibility

Min Age: 2 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy called ssCART-19 (U01) for people with B-cell lymphoma (a type of blood cancer) whose cancer has come back or stopped responding to standard treatments. CAR-T therapy involves taking a patient's own immune cells, engineering them to recognize and attack cancer, and then putting them back into the body. **You may be eligible if...** - You are aged 2 to 75 years old - You have been diagnosed with B-cell lymphoma that has relapsed or not responded after at least two prior treatments - Your tumor cells test positive for a protein called CD19 - You have at least one measurable area of cancer - Your heart, lungs, liver, and kidneys are working adequately - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You have another active cancer - You have active hepatitis B, hepatitis C, HIV, or syphilis - You have an uncontrolled serious infection - You have significant uncontrolled heart problems (e.g., recent heart attack, very low heart pumping function) - You are pregnant or breastfeeding - You have an active autoimmune condition requiring immune-suppressing medications 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

DRUGssCART-19

Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.


Locations(1)

Tongji Hospital of Tongji University

Shanghai, China

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NCT07093073


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