Trial reportLeukemia2026
Comparison of obecabtagene autoleucel versus an external control arm in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
Trial report in Leukemia, 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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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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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0 citing papers in PubMed.
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the single-arm Phase Ib/II FELIX study (NCT04404660), obecabtagene autoleucel (obe-cel; CD19-directed autologous CAR T-cell therapy) demonstrated high overall remission rates (ORR) and a favorable safety profile in adults with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). To contextualize results from FELIX, we compared the efficacy and safety of obe-cel with matched external control arms (ECA) derived from historical trials using propensity score matching. ECAs represented standard of care (SoC) non-CAR T-cell therapies: blinatumomab, inotuzumab ozogamicin, and conventional chemotherapy. The primary endpoint was ORR; secondary endpoints included overall survival (OS). Event-free survival (EFS) and safety were exploratory endpoints. Among the intent-to-treat population in FELIX (n = 107), obe-cel demonstrated significantly higher ORR than non-CAR T-cell therapies (67.3% vs 51.4%; odds ratio 1.9; p = 0.0257). Median OS was longer with obe-cel when censoring for hematopoietic stem cell transplant (15.1 vs 7.0 months; p = 0.0015) and without censoring (13.9 vs 7.8 months; p = 0.0430). EFS was significantly improved with obe-cel (median 9.8 vs 2.5 months; p < 0.0001). Safety profiles were comparable between groups, with similar rates of Grade ≥3 adverse events. Obe-cel offers superior remission rates and survival benefits over current SoC non-CAR T-cell therapies, with an acceptable safety profile; its use could address unmet needs in adult R/R B-ALL.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.