Phase 1/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed/refractory T-cell malignancies

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.

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Publication Details

Journal
Blood
Published
2025-05-30
DOI
https://doi.org/10.1182/blood.2025028387
Citations
8
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
8.36

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article

Phase 1/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed/refractory T-cell malignancies

Rawan Faramand, Jan Davidson‐Moncada, Brett Ramsey, Ryan J. Mattison et al.
8 citations
Blood
CAR-T cell therapy research
8.36
article

Phase 1/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed/refractory T-cell malignancies

Rawan Faramand, Jan Davidson‐Moncada, Brett Ramsey, Ryan J. Mattison, Deborah Masters, André Baruchel, Alexander Hamil, Ashish Bajel, John F. Muth, Eileen McNulty, C. Michel Zwaan, Friso Calkoen, Ibrahim Taha Aldoss, Jan Baughman, Shannon L. Maude, Bhagirathbhai Dholaria, Michael P. Rettig, John F. DiPersio, Anita W. Rijneveld, Matthew Cooper, Tony Wu, Deepa Bhojwani, Haley Irons, Nicolas Boissel, Kenneth Jacobs, Alan S. Wayne, Armin Ghobadi, Ben Capoccia, Ouiam Bakkacha, Justo Gonzalez, María del Rosario, Brent Wood, Stephanie Christ
article en
8 citations

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.

BloodVol. 146(10)
University of Southern California (US), Maxygen (United States) (US), City Of Hope National Medical Center (US), The Royal Melbourne Hospital (AU), Children's Hospital of Philadelphia (US), Children's Hospital of Los Angeles (US), University of Wisconsin–Madison (US), Délégation Paris 7 (FR), University of Health Sciences and Pharmacy (US), Washington University in St. Louis (US), Université Paris Cité (FR), Peter MacCallum Cancer Centre (AU), Erasmus MC (NL), University of California System (US), Moffitt Cancer Center (US), Assistance Publique – Hôpitaux de Paris (FR), University of Wisconsin Carbone Cancer Center (US), City of Hope (US), USC Norris Comprehensive Cancer Center (US), Hôpital Robert-Debré (FR), Princess Máxima Center (NL), Erasmus MC - Sophia Children’s Hospital (NL), Hôpital Saint-Louis (FR), Erasmus MC Cancer Institute (NL), Mersana Therapeutics (United States) (US), Vanderbilt University Medical Center (US)
Amgen, Bristol-Myers Squibb, Pfizer, AstraZeneca, Sanofi, Leukemia and Lymphoma Society, Gilead Sciences, Celgene, Jazz Pharmaceuticals, National Comprehensive Cancer Network, Atara Biotherapeutics, Incyte, Servier, National Institutes of Health, National Cancer Institute
Good health and well-being
Openalex Percentile: Top 2%
CAR-T cell therapy research
8.36
DOIOpen Access PDFOpenAlex
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