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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-75
SponsorShanghai Tongji Hospital, Tongji University School of Medicine

About this trial

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 .

Eligibility criteria

Qualifiers

Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.

Age ≥2 years and ≤75 years at the time of signing the ICF (both sexes eligible). For minors (<18 years), the legal guardian must sign after full disclosure; minors with decision-making capacity must co-sign with their guardians.

Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .

CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months).

Disqualifiers

Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;

Primary immunodeficiency ;

Severe immediate hypersensitivity to any study drug;

Live vaccine administration within 6 weeks prior to screening ;

Trial design

Treatments tested in this trial

  • ssCART-19

Treatment groups

50 Participants
are divided into 1 treatment group