RecruitingPhase 1NCT05528887

Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies


Sponsor

The Affiliated People's Hospital of Ningbo University

Enrollment

10 participants

Start Date

Sep 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR-T cell therapy — a treatment that uses your own immune cells, genetically engineered to attack cancer — in people with blood cancers (lymphoma, myeloma, or leukemia) that have come back or stopped responding to standard treatments. **You may be eligible if...** - You have a confirmed blood cancer (lymphoma, myeloma, or leukemia) that has relapsed or is no longer responding to standard therapy - Your cancer cells test positive for specific surface proteins that the CAR-T cells are designed to target - You are in reasonably good health (ECOG 0–2) with adequate organ function - You are able to understand and sign the consent form **You may NOT be eligible if...** - You have a history of serious heart disease (heart failure class III/IV or ejection fraction below 50%) - You have a second, separate cancer - You have active HIV, Hepatitis B or C, or syphilis infection - You have an uncontrolled infection - 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

BIOLOGICALAutologous CAR-T cells

D0: CAR-T cells will be infused intravenously.

DRUGFludarabine

D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.

DRUGCyclophosphamide

D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.


Locations(1)

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

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NCT05528887


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