Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma
NCT04712864 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-10-03
Summary
This is a Phase 1, first-in-human (FIH), open-label, multicenter, study of LB1901 administered to adult subjects with histologically confirmed CD4+ relapsed or refractory Peripheral T-cell lymphoma (PTCL) (PTCL not otherwise specified \[PTCL-NOS\] and angioimmunoblastic \[AITL\]), or relapsed or refractory cutaneous T-cell lymphoma (CTCL) (Sézary syndrome \[SS\] and mycosis fungoides \[MF\]).
Conditions
- T-Cell Lymphoma
- Peripheral T-Cell Lymphoma Refractory
- Cutaneous T-Cell Lymphoma Refractory
- Cutaneous T-Cell Lymphoma Recurrent
- Peripheral T-Cell Lymphoma Recurrent
Interventions
- BIOLOGICAL
-
LB1901
LB1901 - an autologous CD4-targeted CAR-T immunotherapy
Sponsors & Collaborators
-
Legend Biotech USA Inc
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-13
- Primary Completion
- 2023-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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