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RECRUITING
NCT06381830
PHASE2

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

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2024-01-01

Completion Date

2027-01-01

Last Updated

2024-04-24

Healthy Volunteers

No

Interventions

OTHER

Apheresis

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.

OTHER

Autologous 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.

DRUG

CAR-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