Clinical Study of U01(ssCART-19) in Patients With B-Cell Lymphoma

NCT07093073 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-06

No results posted yet for this study

Summary

This is a single-arm, open-label clinical study evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.

Conditions

  • B Cell Lymphoma

Interventions

DRUG

ssCART-19

Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.

Sponsors & Collaborators

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Wenjun Zhang, Ph.D. · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-23
Primary Completion
2027-01-31
Completion
2029-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093073 on ClinicalTrials.gov