The study follows Legend Biotech’s initial success with cilta-cel, whose PDUFA date is set for November 2021.
Legend Biotech has initiated the phase 1 LB1901-TCL-001 clinical trial (NCT04712864) assessing the anti-CD4 chimeric antigen receptor (CAR) T-cell therapy LB1901 for the potential treatment of relapsed/refractory T-cell lymphoma (TCL).1
The open-label, multicenter study is currently recruiting patients with histologically confirmed CD4+ peripheral TCL and cutaneous TCL. It is being led by Dr. Swaminathan P. Iyer, professor, Lymphoma & Myeloma, The University of Texas MD Anderson Cancer Center.
“We are excited by the promise of LB1901, and we look forward to further evaluating the safety and tolerability of LB1901. Determining the optimal dose for subsequent evaluation is one of the key objectives of this trial,” Lida Pacaud, MD, vice president, clinical development, Legend Biotech, said in a statement.1 “The number of patients who relapse or are refractory to current TCL treatments is significant, and this trial will provide important information about the potential of CAR-T therapy to treat this disease.”
The trial aims to enroll 50 participants and has an estimated completion date of December 2025. Its primary outcome is determining the recommended dose for expansion (RDE) and assessing the safety and tolerability of the RDE. Secondary outcomes include efficacy measures such as overall response rate (ORR), time to response, duration of response, disease control rate, progression-free survival (PFS), and overall survival (OS).
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Legend Biotech is also developing another CAR T-cell therapy, ciltacabtagene autolecel (cilta-cel), for the treatment of relapsed/refractory multiple myeloma (RRMM), in collaboration with Janssen. The FDA previously accepted the biologic license application for cilta-cel in May 2021 and has set the PDUFA date for November 29, 2021.2
Multiple trials have demonstrated cilta-cel's efficacy in RRMM. Legend recently presented longer term data from the phase 1/2 CARTITUDE-1 trial (NCT03548207) at the 2021 ASCO and EHA Annual meetings. These data, from 97 heavily pretreated patients, demonstrated a 98% ORR, an 80% stringent complete response rate, a 66% PFS rate, and an 81% OS rate at 18 months post-treatment.
Results from the phase 2 CARTITUDE-2 trial (NCT04133636) were also presented at the 2021 ASCO and EHA Annual meetings. The data showed early and deep responses in 20 lenalidomide refractory patients with progressive MM after 1-3 prior lines of therapy. Safety was consistent with other trials in the program. The CARTITUDE development program expanded in July 2021 with the addition of the phase 3 CARTITUDE-5 study (NCT04923893) in patients with newly diagnosed MM.
“We have made exciting progress in advancing our first investigational CAR-T therapy ciltacel in the past few months, with key regulatory, data and manufacturing updates. This includes the acceptance of our applications for cilta-cel by the U.S. FDA and EMA and the presentation of additional efficacy and safety data from the CARTITUDE cilta-cel clinical development program at ASCO and EHA Annual meetings,” Ying Huang, PhD, chief executive officer and chief financial officer, Legend Biotech, said in a cimpany update.2 “We look forward to a momentous second half of the year as we work towards bringing cilta-cel to patients living with multiple myeloma and providing their healthcare providers a new therapeutic option, in collaboration with Janssen.”