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

NCT06381830 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-04-24

No results posted yet for this study

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.

Conditions

  • Lymphoma, B-Cell
  • Autologous Stem Cell Transplantation

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).

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Suzhou Hongci Hematology Hospital, Suzhou, China

    collaborator UNKNOWN

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Deipei Wu, M.D. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381830 on ClinicalTrials.gov