Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07059741

Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL

Led by The First Affiliated Hospital of Soochow University · Updated on 2025-07-11

20

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to investigate a novel therapeutic strategy of integrated radiotherapy before autologous stem cell transplantation (ASCT) sequential chimeric antigen receptor T-cell(CAR-T) therapy for patients with relapsed/refractory(R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL). By evaluating the efficacy and safety of this multimodal approach, we seek to provide a theoretical foundation and clinical data to optimize outcomes for relapsed/refractory aggressive B-NHL patients.

CONDITIONS

Official Title

Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed aggressive B-cell non-Hodgkin lymphoma
  • Life expectancy longer than 3 months
  • Cardiac ejection fraction 50% or higher
  • Liver enzymes (ALT and AST) no more than 2 times the upper normal limit
  • Kidney function with serum creatinine clearance 80 mL/min or higher and serum creatinine below 160 mmol/L
  • Lung function with oxygen saturation above 91% without oxygen support
  • Adequate bone marrow function with hemoglobin 90 g/L or higher, platelet count 70 x 10^9/L or higher, and absolute neutrophil count 1.5 x 10^9/L or higher
  • Able to understand and willing to provide written informed consent
  • Willing to use birth control from enrollment until study follow-up if of childbearing potential
Not Eligible

You will not qualify if you...

  • Severe abnormalities in liver or kidney function exceeding 2 times the upper normal limits
  • Presence of symptomatic organic heart disease or abnormal heart function of New York Heart Association class 2 or higher
  • Electrocardiogram QTc interval longer than 500 ms
  • Active hepatitis B or hepatitis C infection
  • Uncontrolled active infections
  • Human immunodeficiency virus infection
  • Other cancers requiring treatment or intervention
  • Current or expected need for systemic corticosteroid therapy
  • Pregnant or breastfeeding women
  • Declining consolidation autologous hematopoietic stem cell transplantation due to financial reasons
  • Psychological conditions preventing study participation or informed consent
  • Unlikely to complete all study visits or procedures as judged by the investigator

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

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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Research Team

C

Changju Qu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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