Study of Novel Off-the-Shelf CAR-T in T-ALL/LBL Launching in 2025
A pivotal phase 2 trial of WU-CART-007, an anti-CD7 CAR T-cell therapy for relapsed/refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma treatment, will begin in 2025.
Microscopic image of CAR T cells - Generated with Google Gemini AI
A phase 2 study evaluating WU-CART-007, a first-in-class, investigational, anti-CD7 chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult and pediatric patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/LBL) is planned to begin in the first quarter of 2025.1
This pivotal phase 2 study will assess WU-CART-007’s safety and efficacy in patients with R/R T-ALL/LBL and T-ALL/LBL. The single-arm study will include 2 cohorts: one of patients with R/R disease and an exploratory cohort of patients with minimal residual disease (MRD)-positive status.
The trial, which is enrolling patients at centers across the US, Europe, Asia, and Australia, marks the first pivotal study of an off-the-shelf, allogeneic CD7-targeted CAR T-cell therapy for this patient population.
“T-ALL/LBL is an aggressive cancer with a significant need for new therapies given that many patients will progress on standard of care,” said Kumar Srinivasan, PhD, Wugen president and chief executive officer, in a press release. “Wugen is well positioned for this critical stage of research and development for WU-CART-007.”
Prior Data on WU-CART-007
WU-CART-007, an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR T-cell therapy, works to overcome the technological challenges of harnessing CAR T cells that aim to treat CD7-positive hematological malignancies. The agent is manufactured through the use of healthy donor-derived T cells and aims to remove the risk of malignant cell contamination that has historically been seen in the autologous CAR T setting.1
In July 2022, the FDA granted WU-CART-007 fast track designation.2 Additionally, the agent has been granted regenerative medicine advanced therapy, orphan drug, and rare pediatric disease designations from the FDA and PRIME designation in the European Union for the treatment of R/R T-ALL and T-LBL.
WU-CART-007 has already been examined in a phase 1/2 trial (NCT04984356) for the treatment of R/R T-ALL/LBL.3 The global, open-label, first-in-human study assessed the safety, recommended dose, and preliminary antitumor activity of WU-CART-007 in this patient population, which includes those aged 12 years and older with adequate renal, hepatic, respiratory, and cardiovascular function, a life expectancy of over 12 weeks, and an ECOG/Karnofsky performance status 0 or 1 at screening (adults age >16) or Lansky performance status of 60 and above (adolescents ≤16).3
The primary end points included safety based on the incidence of adverse events, MTD, overall response rate, duration of response, and progression-free survival. The secondary end points of the study were overall survival and hematopoietic stem cell transplant rate.
Results from the phase 1/2 cohort expansion study showed clinically manageable safety and strong anti-leukemic activity.1 The overall response rate was 91% in heavily pretreated patients with R/R T-ALL/LBL. The updated data from the study are expected to be presented at the 2024 American Society of Hematology Annual Meeting.
REFERENCES:
Wugen to initiate a pivotal trial for its investigational, off-the-shelf, allogeneic, CD7-targeted CAR-T cell therapy, WU-CART-007, in patients with relapsed or refractory T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma. News release. Wugen, Inc. November 12, 2024. Accessed November 12, 2024. https://tinyurl.com/2bbnwpwf
Wugen receives U.S. FDA fast track and rare pediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL. News release. Wugen Inc. July 19, 2022. Accessed November 12, 2024. https://bwnews.pr/3PGPxa1
A phase 1/2 study of the safety and efficacy of anti-CD7 allogeneic CAR-T cells (WU-CART-007) in patients with relapsed or refractory T-ALL/LBL. ClinicalTrials.gov. Updated August 12, 2024. Accessed November 12, 2024. https://clinicaltrials.gov/ct2/show/NCT04984356
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