Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07538635

CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.

Led by Zhejiang Cancer Hospital · Updated on 2026-05-13

20

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.

CONDITIONS

Official Title

CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of large B-cell lymphoma including DLBCL, HGBL, CNSL, PMBCL, or transformed follicular lymphoma
  • Previously treated with a regimen containing anti-CD20 monoclonal antibody and anthracycline
  • Presence of at least one high-risk clinical or molecular factor such as failure to respond after 4 cycles of first-line treatment, relapse within 12 months, relapse after ASCT, CNS involvement at relapse, TP53 gene mutation, or HGBL with MYC and Bcl-2 rearrangements
  • ECOG performance status between 0 and 2
  • Eligible for and planned to receive high-dose chemotherapy and ASCT followed by CAR-T therapy
  • Liver and kidney function within specified limits (ALT/AST ≤ 3× ULN; total bilirubin ≤ 1.5 mg/dL; creatinine ≤ 1.5× ULN or creatinine clearance ≥ 30 mL/min)
  • Left ventricular ejection fraction ≥ 40%
  • Life expectancy of at least 3 months
Not Eligible

You will not qualify if you...

  • Previous treatment with any CD19-targeted therapy
  • Negative CD19 expression confirmed by immunohistochemistry
  • Active hepatitis B or C infection with viral levels above normal limits
  • Uncontrolled infection, cardiovascular or cerebrovascular disease, bleeding disorders, or connective tissue diseases
  • History of HIV infection
  • 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

Zhejiang Cancer Hospital

Hangzhou, Zhengjiang, China, 310022

Actively Recruiting

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Research Team

X

Xi Chen

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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CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors. | DecenTrialz