Skip to content

A Single-Arm, Open-Label, Multicenter, Phase 1b/2 Study Evaluating the Safety and Efficacy of AUTO1 (obecabtagene autoleucel [obe-cel]) in Pediatric Patients with CD19-positive Relapsed/Refractory (R/R) B cell Acute Lymphoblastic Leukemia (B ALL) or R/R Aggressive Mature B Cell Non–Hodgkin Lymphoma (B NHL)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506307-26-00
Acronym
AUTO1-PY1
Enrollment
14
Registered
2023-09-15
Start date
2024-05-22
Completion date
Unknown
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL).

Brief summary

B ALL Cohort: Proportion of pediatric participants with r/r B ALL at screening who achieve CR within 3 months of obe-cel infusion per IRRC assessment, B ALL Cohort: Proportion of pediatric participants with r/r B ALL at screening who achieve ORR (CR + CRi) within 3 months of obe-cel infusion per IRRC assessment, B ALL and B NHL Cohorts: Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) after receiving obe-cel infusion, B ALL and B NHL Cohorts: Incidence and duration of severe hypogammaglobulinemia

Detailed description

B-ALL Cohort (Key Secondary): Proportion of pediatric participants with r/r B ALL with successful ClonoSEQ® NGS MRD calibration who achieve MRD-negative ORR below the 10-4 level (< 0.01%) within 3 months of obe-cel infusion per IRRC assessment, B-NHL Cohort (Secondary): • ORR (CR + PR) • Duration of response (DoR); • Progression free survival (PFS); • Overall survival (OS); • Incidence of CD19-negative relapse., B ALL Cohort (Secondary): • CR at any time • ORR (CR + CRi) at any time • MRD-negative ORR below the 10-4 level (< 0.01%) at any time • Duration of Remission (DoR) • Event Free Survival (EFS) • Overall Survival (OS) • Proportion of participants undergoing HSCT while still in CR/CRi following obe-cel • Incidence of CD19-negative relapse at any time

Interventions

Sponsors

Autolus Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
B ALL Cohort: Proportion of pediatric participants with r/r B ALL at screening who achieve CR within 3 months of obe-cel infusion per IRRC assessment, B ALL Cohort: Proportion of pediatric participants with r/r B ALL at screening who achieve ORR (CR + CRi) within 3 months of obe-cel infusion per IRRC assessment, B ALL and B NHL Cohorts: Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) after receiving obe-cel infusion, B ALL and B NHL Cohorts: Incidence and duration of severe hypogammaglobulinemia

Secondary

MeasureTime frame
B-ALL Cohort (Key Secondary): Proportion of pediatric participants with r/r B ALL with successful ClonoSEQ® NGS MRD calibration who achieve MRD-negative ORR below the 10-4 level (< 0.01%) within 3 months of obe-cel infusion per IRRC assessment, B-NHL Cohort (Secondary): • ORR (CR + PR) • Duration of response (DoR); • Progression free survival (PFS); • Overall survival (OS); • Incidence of CD19-negative relapse., B ALL Cohort (Secondary): • CR at any time • ORR (CR + CRi) at any time • MRD-negative ORR below the 10-4 level (< 0.01%) at any time • Duration of Remission (DoR) • Event Free Survival (EFS) • Overall Survival (OS) • Proportion of participants undergoing HSCT while still in CR/CRi following obe-cel • Incidence of CD19-negative relapse at any time

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026