RecruitingPhase 1NCT07453446

Clinical Study of U29 Injection (CD30-CART) in Patients With CD30-Positive Relapsed/Refractory Lymphoma

A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CD30-targeted Chimeric Antigen Receptor T (CAR-T) Cell Injection in Patients With CD30-positive Relapsed or Refractory Lymphoma


Sponsor

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

Enrollment

18 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, open-label study conducted in subjects with relapsed or refractory CD30-positive lymphoma, with priority given to Hodgkin lymphoma and anaplastic large cell lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests an experimental CAR-T cell therapy called U29 Injection—a treatment where your own immune cells are taken out, genetically modified in a lab to better recognize and attack cancer cells, and then returned to your body—for patients with a type of blood cancer called lymphoma that carries a protein called CD30 on its surface and has come back or stopped responding to treatment. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with Hodgkin lymphoma, anaplastic large cell lymphoma, or another CD30-positive lymphoma that has relapsed or not responded to treatment - You have failed at least two prior lines of chemotherapy (or a stem cell transplant) - You are in reasonable physical condition (ECOG 0–3) - Your heart, liver, kidneys, and blood counts meet minimum function requirements **You may NOT be eligible if...** - You have had prior CAR-T or gene-modified cell therapy - You have active uncontrolled infection, HIV, active hepatitis B or C, or syphilis - You have had a recent heart attack, severe heart failure, or dangerous heart rhythm problems - You have an active autoimmune disease or active graft-versus-host disease - 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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Interventions

DRUGCD30 CAR-T Cells

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)

Hebei Yanda Lu Daopei Hospital

Sanhe, China

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NCT07453446