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. 

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”