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
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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