CD22 CAR T cells demonstrate high response rates and safety in pediatric and adult B-ALL: Phase 1b results.
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
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Immunotherapy, Adoptive
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Sialic Acid Binding Ig-like Lectin 2
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Receptors, Chimeric Antigen
Limits:
Adolescent
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Adult
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Child
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Child, preschool
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Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
Leukemia
Year:
2024
Document type:
Article