RecruitingPhase 2NCT06381830

Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma

Clinical Study of the Efficacy and Safety of Chimeric Antigen Receptor T-cell Therapy Following Autologous Stem Cell Transplantation for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

64 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding CAR-T cell therapy (engineered immune cells that attack cancer) after an autologous stem cell transplant (a transplant using your own stem cells) improves outcomes in patients with relapsed or treatment-resistant large B-cell non-Hodgkin's lymphoma. **You may be eligible if...** - You are between 18 and 65 years old - You have large B-cell lymphoma that has relapsed or not responded to prior treatment - You have had at least one prior treatment - Your cancer has measurable tumor lesions - Your heart, kidney, and liver function are adequate - Your blood counts meet minimum requirements **You may NOT be eligible if...** - You are outside the 18-65 age range - You have very poor organ function or blood counts - You are pregnant or unwilling to use contraception - You have active uncontrolled infections 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

OTHERApheresis

Participants will undergo two separate apheresis procedures, including: G-CSF primed hematopoietic stem cell collection and peripheral blood mononuclear cell apheresis for CAR-T cell manufacturing.

OTHERAutologous Stem Cell Transplantation

Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10\^6 CD34+ stem cells/kilogram.

DRUGCAR-T Cell Therapy

CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10\^6 CAR-T/kg,ivgtt).


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06381830


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