Trial reportCancer research communications2026
CAR T-cell Kinetics, Persistence, and Clinical Outcomes in Adult Patients with Relapsed/Refractory B-cell ALL Treated with Obecabtagene Autoleucel in the FELIX Study.
Trial report in Cancer research communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04404660 (An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia), which is not on this map. Not yet cited in PubMed.
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An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia
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24 authors.
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Abstract
Assessments of chimeric antigen receptor (CAR) T-cell pharmacokinetics by flow cytometry (FC) and a droplet digital PCR (ddPCR) assay were compared in adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) following treatment with obecabtagene autoleucel (obe-cel) in the phase Ib/II FELIX study (NCT04404660). CAR T-cell persistence and B-cell aplasia (BCA) were then correlated with event-free survival (EFS). Peripheral blood (PB) samples collected from 127 obe-cel-infused patients were tested by FC and ddPCR. The Spearman correlation coefficient was used to measure the correlation between the number of CAR T-positive cells by FC and ddPCR. The impact of CAR T-cell persistence and BCA (B cells <20 cells/μL by FC in PB) on EFS was assessed using Cox proportional hazards regression. ddPCR was observed to statistically correlate with both the surface (0.60, P < 0.0001) and intracellular FC assays (0.74, P < 0.0001). A higher sensitivity for detecting CAR T-cell positive samples was observed with ddPCR, with 58.8% and 41.3% of samples negative by surface and intracellular FC, respectively, being positive by ddPCR. Loss of CAR T-cell persistence (HR, 2.7; 95% CI, 1.4-5.4) and, to a lesser degree, B-cell recovery (HR, 1.7; 95% CI, 0.7-3.8) as time-dependent variables and at month 3 were associated with poorer EFS. ddPCR demonstrated enhanced sensitivity over FC methods for detection of obe-cel persistence. Additionally, ongoing persistence and BCA were associated with longer EFS and may be taken into consideration, together with clinical parameters, in informing decision making. SIGNIFICANCE: In patients with R/R B-ALL treated with obe-cel, ddPCR assessment of CAR transgene levels produced results consistent with FC while providing superior sensitivity. ddPCR-detected CAR T-cell persistence at month 3 and at any time after infusion correlated with longer EFS versus loss of persistence, therefore potentially informing clinical decision making.
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