A Phase Ib/II Exploratory Clinical Trial of Memory-Enhanced 7×19-THEMIS CAR-T Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma
NCT07788118 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-08-26
Summary
This study is aimed to explored the safety and efficacy of 7×19-THEMIS CAR-T cell therapy for large B-cell lymphoma and to conduct an exploratory comparison of the 3-month objective response rate (ORR) and complete remission rate (CR rate) between the experimental cohort and the historical control cohort (NCT04833504).
Conditions
- Relapsed/Refractory Large B-cell Lymphoma (LBCL)
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- Transforming Follicular Lymphoma (tFL)
- Mantle Cell Lymphoma (MCL)
Interventions
- BIOLOGICAL
-
7×19-THEMIS CAR-T cells
IL7 and CCL19 Armed anti-CD19 CAR-T with coexpressing Themis
Sponsors & Collaborators
-
Second Affiliated Hospital, Zhejiang University, School of Medicine
lead OTHER
Principal Investigators
-
Wenbin Qian,Professor · Second Affiliated Hospital, Zhejiang University, School of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2029-09-01
- Completion
- 2031-09-01
Countries
- China
Study Locations
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