RecruitingEarly Phase 1NCT06756321

A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy

An Exploratory Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor T-Cells (CAR T-Cells) in Subjects with Relapsed/Refractory Hematologic Malignancy

Sponsor

Affiliated Hospital of Nantong University

Enrollment

9 participants

Start Date

Sep 18, 2023

Study Type

INTERVENTIONAL

Conditions

Relapsed/refractory Lymphoma Relapsed/Refractory Leukemia

Summary

This study is a single-center, open-label clinical trial of single-dose of CAR T-cells in subjects with relapsed/refractory hematologic malignancy.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR T-cell therapy — a treatment that engineers a patient's own immune cells to fight cancer — in people with blood cancers (like leukemia and lymphoma) that have come back or stopped responding to standard treatments. **You may be eligible if...** - You are between 18 and 70 years old - You have a blood cancer (such as B-cell leukemia, lymphoma, or Hodgkin lymphoma) that has relapsed or not responded to standard therapy including stem cell transplant - Your cancer cells have specific markers (CD19, CD20, CD30, or similar) that CAR T-cells can target - You are in reasonably good health and have adequate heart, lung, kidney, and liver function **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal fluid (with symptoms) - You have an uncontrolled active infection - You have active hepatitis B, hepatitis C, HIV, or syphilis - You are pregnant or breastfeeding - You have significant heart disease or a history of other cancers 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

BIOLOGICALanti-CD19-CAR T-cells, or anti-CD30-CAR T-cells, or anti-CD20/CD30-CAR T-cells

Each subject will be infused with single dose. A classic "3+3" dose escalation will be employed. anti-CD19-CAR T-cells Dose level 1：1x10\^5 CAR T cells/kg, Dose level 2：3x10\^5 CAR T cells/kg, Dose level 3：1x10\^6 CAR T cells/kg anti-CD30-CAR T-cells Dose level 1：3x10\^6 CAR T cells/kg, Dose level 2：6x10\^6 CAR T cells/kg, Dose level 3：1x10\^7 CAR T cells/kg anti-CD20/CD30-CAR T-cells Dose level 1：1x10\^6 CAR T cells/kg, Dose level 2：3x10\^6 CAR T cells/kg, Dose level 3：1x10\^7 CAR T cells/kg

DRUGFludarabine

Fludarabine will be given at a dose of 25 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

DRUGCyclophosphamide

Cyclophosphamide will be given at a dose of 250 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

Locations(1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

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NCT06756321