Anti-CD7 allogeneic WU-CART-007 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma: a phase 1/2 trial

Author:

Ghobadi Armin1,Aldoss Ibrahim2ORCID,Maude Shannon3,Bhojwani Deepa4ORCID,Wayne Alan5ORCID,Bajel Ashish6,Dholaria Bhagirathbhai7ORCID,Faramand Rawan8,Mattison Ryan9,Rijneveld Anita10,Zwaan C.11,Calkoen Frisco12,Baruchel Andre13,BOISSEL Nicolas14ORCID,Rettig Michael15ORCID,Wood Brent16,Jacobs Kenneth17,Christ Stephanie1,Irons Haley18,Capoccia Ben18,Gonzalez Justo18,Wu Tony18,Rosario Maria del18,Hamil Alexander18,Bakkacha Ouiam18,Muth John18,Ramsey Brett18,McNulty Eileen18,Cooper Matthew18,Baughman Jan19,Davidson-Moncada Jan18,DiPersio John20ORCID

Affiliation:

1. Washington University School of Medicine

2. City of Hope National Medical Center

3. University of Pennsylvania

4. CHLA

5. Children's Hospital Los Angeles

6. Peter MacCallum Cancer Center

7. Vanderbilt University Medical Center

8. Moffitt Cancer Center

9. University of Wisconsin Carbone Cancer Center

10. Erasmus Medical Center

11. Erasmus Medical Center-Sophia Children’s Hospital

12. Prinses Máxima Centrum

13. University Hospital Robert Debré and University Paris Diderot

14. aphp hôpital saint louis paris

15. Washington University in St Louis

16. University of Southern California

17. Mersana Therapeutics

18. Wugen

19. Alviso Clinical Research

20. Washington University in St. Louis

Abstract

Abstract

Relapsed/refractory T-cell acute lymphoblastic leukemia (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 one 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 26 patients enrolled, 13 received the recommended phase 2 dose (RP2D) of 900 million 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). Biochemical abnormalities consistent with grade 2 hemophagocytic lymphohistiocytosis were seen in one patient (3.8%). Grade 1 immune effector cell-associated neurotoxicity syndrome events (7.7%) and one grade 2 acute graft-vs-host disease event occurred. Grade 5 events (11.5%) were due to fungal infection and multi-organ failure. The composite complete remission rate was 81.8% among 11/13 patients evaluable for response at the RP2D. 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. ClinicalTrials.gov registration: NCT04984356.

Publisher

Springer Science and Business Media LLC

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