Research & Development
Legend Biotech Begins Phase 1 Clinical Trial in the US to Evaluate Investigational Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma
13 September 2021 - - US-based biopharmaceutical company Legend Biotech Corp. (NASDAQ: LEGN) has started a Phase 1 clinical trial in the United States for LB1901, an investigational autologous CD4-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma, the company said.

LB1901 targets CD4, a surface membrane glycoprotein uniformly expressed in most TCL subtypes. The trial follows the US Food and Drug Administration clearance of the Investigational New Drug application submitted by Legend Biotech.

The Phase 1 trial is being led by Dr. Swaminathan P. Iyer, Professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, and is an open label, multi-center and multicohort clinical study in patients with relapsed or refractory PTCL or CTCL (NCT04712864). Recruitment in the trial has begun in the US

T-cell lymphoma is a heterogeneous group of lymphoid malignancies that account for less than 15 % of non-Hodgkin's lymphoma cases in the US.

PTCL comprises subtypes that are uncommon and often aggressive, with a five-year overall survival of only 39%.

CTCL are a group of T-cell malignancies that occur primarily in the skin.v Despite current treatment options, a substantial proportion of patients with PTCL or CTCL experiences relapse. A high unmet medical need remains for patients with relapsed or refractory PTCL and CTCL.

LB1901-TCL-001 (NCT04712864) is a Phase 1 open-label, multicenter study of LB1901 in patients with histologically confirmed CD4+ RR PTCL (PTCL not otherwise specified, or PTCL-NOS, and angioimmunoblastic T cell lymphoma, or AITL) or RR CTCL (mycosis fungoides and Sézary syndrome).

The primary objectives are to characterize the safety and tolerability of LB1901 and determine the optimal dose.

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications.

Its team of over 900 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.


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