Wugen has dosed the first subject in a Phase I/II clinical trial of CAR-T cell therapy, WU-CART-007, to treat relapsed or refractory (R/R) T-cell acute lymphoblastic leukaemia (T-ALL)/lymphoblastic lymphoma (LBL). 

An off-the-shelf, fratricide-resistant CD7-targeted therapy, WU-CART-007 has been designed to address technological issues of using CAR-T cells for the treatment of CD7+ haematological malignancies. 

It is made with T-cells obtained from healthy donors to eradicate the malignant cell contamination risk seen in the autologous CAR-T setting. 

WU-CART-007 is the first off-the-shelf allogeneic CAR-T cell therapy addressing T-Cell malignancies to enter clinical trials in the US.

Furthermore, the therapy obtained orphan drug designation from the US Food and Drug Administration (FDA) to treat ALL.

The multicentre, open-label, international Phase I/II trial will assess the safety and clinical efficacy of WU-CART-007 in R/R T-ALL/LBL patients. 

Phase I portion of the trial will evaluate the safety and tolerability of a single CAR-T cell therapy dose after lymphodepleting conditioning therapy. 

It will also detect the recommended Phase II dose (RP2D), pharmacodynamics and cellular kinetics. 

Phase II segment will evaluate WU-CART-007’s initial anti-tumour activity as assessed by duration of response and objective response rate.

Wugen president and CEO Dan Kemp said: “The dosing of the first patient in our Phase I/II 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. 

“We are also pleased to have received FDA Orphan Drug Designation for WU-CART-007, which further augments our efforts to deliver this therapy to patients in an area of great unmet need.”