Phase 1/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed/refractory T-cell malignancies
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT: Relapsed/refractory T-cell acute lymphoblastic leukemia (ALL; T-ALL)/lymphoma (LBL) represent a significant unmet medical need. WU-CART-007 is a CD7-targeting, allogeneic, fratricide-resistant chimeric antigen receptor T-cell product generated from healthy donor T cells. WU-CART-007 was evaluated in a phase 1/2 study with a 3+3 dose-escalation design followed by cohort expansion in relapsed/refractory T-ALL/LBL. Patients received 1 infusion of WU-CART-007 after standard or enhanced lymphodepleting chemotherapy. The primary objectives, to characterize safety and assess the composite complete remission rate, were met. Of 28 patients enrolled, 13 received the recommended phase 2 dose (RP2D) of 900 × 106 cells of WU-CART-007 with enhanced lymphodepletion. The most common treatment-related adverse event was cytokine release syndrome (88.5%; 19.2% grade 3-4). Two grade 1 immune effector cell-associated neurotoxicity syndrome events (7.7%) and 1 grade 2 acute graft-versus-host disease event occurred (3.8%). One grade 2 immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome was observed. Among the 11 patients evaluable for response at the RP2D who received enhanced lymphodepleting chemotherapy, the overall response rate was 90.9%, and the composite complete remission rate was 72.7%. WU-CART-007 at the RP2D demonstrated a high response rate in patients with relapsed/refractory T-ALL/LBL and has the potential to provide a new treatment option. This trial was registered at www.ClinicalTrials.gov as #NCT04984356.
Source: Blood
Authors: Armin Ghobadi, Ibrahim Aldoss, Shannon L. Maude, Deepa Bhojwani, Alan S. Wayne, Ashish Bajel, Bhagirathbhai Dholaria, Rawan Faramand, Ryan J. Mattison, Anita Rijneveld, C. Michel Zwaan, Friso Calkoen, Andre Baruchel, Nicolas Boissel, Michael Rettig, Brent Wood, Kenneth Jacobs, Stephanie Christ, Haley Irons, Ben Capoccia, Deborah Masters, Justo Gonzalez, Tony Wu, Maria del Rosario, Alexander Hamil, Ouiam Bakkacha, John Muth, Brett Ramsey, Eileen McNulty, Jan Baughman, Matthew L. Cooper, Jan Davidson-Moncada, John F. DiPersio
Institutions: Washington University in St. Louis, City Of Hope National Medical Center, Children's Hospital of Philadelphia, University of Southern California, Children's Hospital of Los Angeles, USC Norris Comprehensive Cancer Center, The Royal Melbourne Hospital, Peter MacCallum Cancer Centre, Vanderbilt University Medical Center, Moffitt Cancer Center, University of Wisconsin–Madison, University of Wisconsin Carbone Cancer Center, Erasmus MC, Erasmus MC Cancer Institute, Princess Máxima Center, Erasmus MC - Sophia Children’s Hospital, Université Paris Cité, Assistance Publique – Hôpitaux de Paris, Hôpital Robert-Debré, Hôpital Saint-Louis, Université Paris Diderot, Mersana Therapeutics (United States)
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4410889404