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CD22 CAR T cells demonstrate high response rates and safety in pediatric and adult B-ALL: Phase 1b results.
Schultz, Liora M; Jeyakumar, Nikeshan; Kramer, Anne Marijn; Sahaf, Bita; Srinagesh, Hrishi; Shiraz, Parveen; Agarwal, Neha; Hamilton, Mark; Erickson, Courtney; Jacobs, Ashley; Moon, Jennifer; Baggott, Christina; Arai, Sally; Bharadwaj, Sushma; Johnston, Laura J; Liedtke, Michaela; Lowsky, Robert; Meyer, Everett; Negrin, Robert; Rezvani, Andrew; Shizuru, Judy; Sidana, Surbhi; Egeler, Emily; Mavroukakis, Sharon; Tunuguntla, Ramya; Gkitsas-Long, Nikolaos; Retherford, Aidan; Brown, Annie Kathleen; Gramstrap-Petersen, Anne-Louise; Ibañez, Raquel Martin; Feldman, Steven A; Miklos, David B; Mackall, Crystal L; Davis, Kara L; Frank, Matthew; Ramakrishna, Sneha; Muffly, Lori.
Affiliation
  • Schultz LM; Division of Pediatric Hematology/Oncology, Stanford University, Stanford, CA, USA.
  • Jeyakumar N; Center for Cancer Cell Therapy, Stanford University, Stanford, CA, USA.
  • Kramer AM; Division of Hematology, Stanford University, Stanford, CA, USA.
  • Sahaf B; Center for Cancer Cell Therapy, Stanford University, Stanford, CA, USA.
  • Srinagesh H; Center for Cancer Cell Therapy, Stanford University, Stanford, CA, USA.
  • Shiraz P; Division of Hematology, Stanford University, Stanford, CA, USA.
  • Agarwal N; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Hamilton M; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Erickson C; Division of Hematology, Stanford University, Stanford, CA, USA.
  • Jacobs A; Division of Pediatric Hematology/Oncology, Stanford University, Stanford, CA, USA.
  • Moon J; Division of Pediatric Hematology/Oncology, Stanford University, Stanford, CA, USA.
  • Baggott C; Division of Pediatric Hematology/Oncology, Stanford University, Stanford, CA, USA.
  • Arai S; Division of Pediatric Hematology/Oncology, Stanford University, Stanford, CA, USA.
  • Bharadwaj S; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Johnston LJ; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Liedtke M; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Lowsky R; Division of Hematology, Stanford University, Stanford, CA, USA.
  • Meyer E; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Negrin R; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Rezvani A; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Shizuru J; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Sidana S; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Egeler E; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Mavroukakis S; Center for Cancer Cell Therapy, Stanford University, Stanford, CA, USA.
  • Tunuguntla R; Center for Cancer Cell Therapy, Stanford University, Stanford, CA, USA.
  • Gkitsas-Long N; Laboratory for Cell and Gene Medicine, Stanford University, Stanford, CA, USA.
  • Retherford A; Laboratory for Cell and Gene Medicine, Stanford University, Stanford, CA, USA.
  • Brown AK; Laboratory for Cell and Gene Medicine, Stanford University, Stanford, CA, USA.
  • Gramstrap-Petersen AL; Laboratory for Cell and Gene Medicine, Stanford University, Stanford, CA, USA.
  • Ibañez RM; Laboratory for Cell and Gene Medicine, Stanford University, Stanford, CA, USA.
  • Feldman SA; Laboratory for Cell and Gene Medicine, Stanford University, Stanford, CA, USA.
  • Miklos DB; Center for Cancer Cell Therapy, Stanford University, Stanford, CA, USA.
  • Mackall CL; Laboratory for Cell and Gene Medicine, Stanford University, Stanford, CA, USA.
  • Davis KL; Center for Cancer Cell Therapy, Stanford University, Stanford, CA, USA.
  • Frank M; Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.
  • Ramakrishna S; Division of Pediatric Hematology/Oncology, Stanford University, Stanford, CA, USA.
  • Muffly L; Center for Cancer Cell Therapy, Stanford University, Stanford, CA, USA.
Leukemia ; 38(5): 963-968, 2024 May.
Article in En | MEDLINE | ID: mdl-38491306
ABSTRACT
Chimeric antigen receptor (CAR) T cells targeting CD22 (CD22-CAR) provide a therapeutic option for patients with CD22+ malignancies with progression after CD19-directed therapies. Using on-site, automated, closed-loop manufacturing, we conducted parallel Phase 1b clinical trials investigating a humanized CD22-CAR with 41BB costimulatory domain in children and adults with heavily treated, relapsed/refractory (r/r) B-ALL. Of 19 patients enrolled, 18 had successful CD22-CAR manufacturing, and 16 patients were infused. High grade (3-4) cytokine release syndrome (CRS) and immune effector-cell-associated neurotoxicity syndrome (ICANS) each occurred in only one patient; however, three patients experienced immune-effector-cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). Twelve of 16 patients (75%) achieved CR with an overall 56% MRD-negative CR rate. Duration of response was overall limited (median 77 days), and CD22 expression was downregulated in 4/12 (33%) available samples at relapse. In summary, we demonstrate that closed-loop manufacturing of CD22-CAR T cells is feasible and is associated with a favorable safety profile and high CR rates in pediatric and adult r/r B-ALL, a cohort with limited CD22-CAR reporting.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / Immunotherapy, Adoptive / Sialic Acid Binding Ig-like Lectin 2 / Receptors, Chimeric Antigen Limits: Adolescent / Adult / Child / Child, preschool / Female / Humans / Male / Middle aged Language: En Journal: Leukemia Year: 2024 Document type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / Immunotherapy, Adoptive / Sialic Acid Binding Ig-like Lectin 2 / Receptors, Chimeric Antigen Limits: Adolescent / Adult / Child / Child, preschool / Female / Humans / Male / Middle aged Language: En Journal: Leukemia Year: 2024 Document type: Article