NCT04712864

Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma

A Phase 1, First-In-Human, Open-Label, Multicenter, Multicohort Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Legend Biotech USA Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[MF\]).

Detailed description

Study Design: This is a Phase 1, first-in-human (FIH), open-label, multicenter, multicohort 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

Type	Name	Description
BIOLOGICAL	LB1901	LB1901 - an autologous CD4-targeted CAR-T immunotherapy

Timeline

• Start date: 2021-09-13
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2021-01-15
• Last updated: 2023-10-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study