Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06365671

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

Led by Ruijin Hospital · Updated on 2026-01-06

16

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors

CONDITIONS

Official Title

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed B-cell non-Hodgkin's lymphoma including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma
  • Relapsed or refractory disease after anti-CD20 monoclonal antibody and anthracycline chemotherapy with specific criteria for progression or response
  • Presence of at least one high-risk factor: extranodal involvement, bulky mass 5 cm or larger, or TP53 gene alterations
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Eligible for high-dose chemotherapy and autologous stem cell transplant and planned for sequential CAR-T treatment
  • Adequate kidney and liver function with specified laboratory values
  • Cardiac ejection fraction of 40% or higher
  • Baseline oxygen saturation above 95% on room air
  • Life expectancy of 3 months or more
Not Eligible

You will not qualify if you...

  • Previous autologous or allogeneic stem cell transplantation
  • Active hepatitis B or C infection with abnormal viral DNA levels
  • Uncontrolled infections, cardiovascular or cerebrovascular disease, blood clotting disorders, or connective tissue diseases
  • History of HIV infection
  • Prior CD19-targeted chimeric antigen receptor cellular immunotherapy
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Actively Recruiting

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Research Team

W

Weili Zhao

CONTACT

L

Li Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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