Actively Recruiting

Phase 1
Phase 2
Age: 2Years - 75Years
All Genders
NCT06987916

Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma

Led by Shanghai Tongji Hospital, Tongji University School of Medicine · Updated on 2025-06-05

50

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .

CONDITIONS

Official Title

Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma

Who Can Participate

Age: 2Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 2 to 75 years (both sexes eligible; minors require guardian consent)
  • Confirmed diagnosis of B-cell lymphoma per NCCN guidelines
  • Prior treatment failure or relapse after first- or second-line therapies including CD20 monoclonal antibody and anthracycline-based regimens
  • CD19 positive tumor confirmed by immunohistochemistry
  • At least one measurable lesion per Lugano Lymphoma Response Criteria
  • ECOG performance status score between 0 and 3
  • Adequate bone marrow reserve with absolute lymphocyte count  0.3�D710�B9/L and platelet count  30�D710�B9/L
  • Adequate organ function including liver enzymes, bilirubin, creatinine or creatinine clearance, oxygen saturation, cardiac function, and coagulation parameters
  • Negative pregnancy test within 7 days before CAR-T infusion for women of childbearing potential and agreement to use effective contraception during and for at least 1 year after treatment
  • Suitable venous access for leukapheresis or blood collection
  • Expected survival of at least 3 months
Not Eligible

You will not qualify if you...

  • Concurrent malignancies except those with disease-free survival over 3 years or carcinoma in situ
  • Active viral infections including hepatitis B, hepatitis C, HIV, or syphilis above detection limits
  • Uncontrolled infections of any type
  • Significant central nervous system diseases such as epilepsy, stroke, dementia, cerebellar disorders, or CNS autoimmune diseases
  • Recent cardiac procedures within 12 months or significant cardiac conditions including congestive heart failure, myocardial infarction, unstable angina, prolonged QTc interval, or reduced left ventricular function
  • Primary immunodeficiency
  • Severe immediate hypersensitivity to any study drug
  • Live vaccine administration within 6 weeks prior to screening
  • Pregnancy or lactation
  • Active autoimmune diseases
  • Participation in another interventional clinical trial within 30 days prior to consent
  • Any other conditions deemed ineligible 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

Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)

Shanghai, Shanghai Municipality, China, 200065

Actively Recruiting

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Research Team

W

Wenjun Zhang, Doctor

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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