First Patient Dosed in T-Cell Malignancy CAR T-Cell Therapy Trial

The first patient has been dosed in the phase 1/2 trial (NCT04984356) of Wugen’s WU-CART-007, which is being explored for the potential treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).

“The dosing of the first patient in our Phase 1/2 trial for R/R T-ALL/LBL is a significant milestone as we continue to advance the first, off-the-shelf allogeneic CAR-T cell therapy for T-Cell malignancies in the United States into the clinic,” Dan Kemp, PhD, president and chief executive officer, Wugen, said in a statement.

Notably, the investigational cell therapy has also received orphan drug designation from the FDA.

WU-CART-007 is an off-the-shelf, fratricide-resistant CD7-targetedchimeric antigen receptor (CAR) T-cell therapy that is being assessed in R/R T-ALL and LBL in a first-in-human, multi-site, global, open-label, phase 1/2 study.

The first phase of the study will evaluate safety and tolerability, cellular kinetics, and pharmacodynamics of a single dose of the therapy after lymphodepletion and determine a recommended phase 2 dose. This dose will be assessed for preliminary anti-tumor activity in the second phase of the study via objective response rate and duration of response. Secondary outcomes of the study include overall survival and hematopoietic stem cell transplant rate.

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“Globally, about 11,000 patients are diagnosed with T-ALL/LBL every year. About half of these patients are either resistant to frontline therapy or relapse even after initial remission, and are ultimately left with very limited treatment options,” principal investigator Armin Ghobadi, MD, associate professor of medicine, Division of Medical Oncology, Washington University School of Medicine, added to the statement. “Nelarabine is the only FDA approved therapy for R/R T-ALL, and for more than a decade, no other advances have been made for this patient population. We look forward to advancing WU-CART-007, which has the potential to transform the care paradigm for these patients.”

CGTLive previously discussed WU-CART-007 as well as the company’s lead candidate, WU-NK-101, with Wugen’s chief medical officer, Jan Davidson, MD, PhD. WU-NK-101 is a natural killer cell therapy candidate currently being evaluated in phase 1/2 studies (NCT04893915) for the potential treatment of acute myeloid leukemia. It is also in preclinical studies in head and neck cancer, melanoma, and other solid tumors. Davidson discussed both Wugen’s CAR T and NK platforms in the video below.

REFERENCE

Wugen Announces First Patient Dosed in Phase 1/2 Trial of WU-CART-007 for the Treatment of Patients with R/R T-ALL/LBL. News release. Wugen. March 15, 2022. https://www.businesswire.com/news/home/20220315005264/en/Wugen-Announces-First-Patient-Dosed-in-Phase-12-Trial-of-WU-CART-007-for-the-Treatment-of-Patients-with-RR-T-ALLLBL