TriangleNCT04404660 · CITED IN SOURCE DOCUMENTS
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-04-08
This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (ALL).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Age 18 years or older * ECOG performance status of 0 or 1 * Relapsed or refractory B cell ALL * Patients with Ph+ ALL are eligible if intolerant to TKI, failed two lines of any TKI, or failed one line of second-generation TKI, or if TKI is contraindicated * Documented CD19 positivity within 1 month of screening * Phase 1b: Primary Cohort IA: Presence of ≥5% blasts in BM at screening * Phase 1b: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and \<5% blasts in the BM at screening * Phase 2: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening * Phase 2: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central NGS testing and \<5% blasts in the BM at screening * Adequate renal, hepatic, pulmonary, and cardiac function Exclusion Criteria: * Phase 1b (Cohort IA and Cohort IB) and Phase 2 (Cohort IIA and Cohort IIB) B-ALL with isolated EM disease * Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis * History or presence of clinically relevant CNS pathology * Presence of CNS-3 disease or CNS-2 disease with neurological changes * Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management * Active or latent Hepatitis B virus or active Hepatitis C virus * Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test * Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Biological: AUTO1
- label
- AUTO1
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- AUTO1
- description
- Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a total target dose of 410E+6 of CD19-positive CAR T cells as a split dose on Day 1 and on Day 10 (±2 days).
- name
- AUTO1
- other Names
- Obecabtagene autoleucel (obe-cel)
- type
- BIOLOGICAL
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 153
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Phase 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
- time Frame
- Up to 24 months
- measure
- Phase 2 - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC.
- time Frame
- Up to 24 months
- secondary Outcomes
- measure
- Phase 2 - Proportion of patients achieving MRD-negative CR
- time Frame
- Up to 24 months
- measure
- Phase 2 - Complete remission rate
- time Frame
- Up to 24 months
- measure
- Phase 2 - Response to AUTO1 treatment measured as duration of remission (DOR)
- time Frame
- Up to 24 months
- measure
- Phase 2 - Response to AUTO1 measured as progression-free survival (PFS).
- time Frame
- Up to 24 months
- measure
- Phase 2 -Response to AUTO1 treatment measured as overall survival (OS)
- time Frame
- Up to 24 months
- measure
- Phase 2 - Frequency and severity of AEs and SAEs
- time Frame
- Up to 24 months
- measure
- Phase 2 - Incidence of severe hypogammaglobulinemia
- time Frame
- Up to 24 months
- measure
- Phase 2 - Duration of severe hypogammaglobulinemia
- time Frame
- Up to 24 months
- measure
- Phase 2 - Detection of CAR T cells measured following AUTO1 infusion
- time Frame
- Up to 24 months
Full study description
- brief Summary
- This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (ALL).
- detailed Description
- This Phase 1b/2, open-label, multi-center, single arm study is designed to evaluate the safety and efficacy of AUTO1 in adult patients with B-cell ALL by determining the overall response rate (ORR). Adult patients with r/r ALL will be enrolled in both phases of the study. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. All patients will receive a total target dose of 410E+6 of CAR T cells as a split dose on Day 1 and on Day 10 (± 2 days).
Source references
- references
- citation
- Jabbour E, Sandhu KS, Shaughnessy P, Logan AC, Abedi M, Shah BD, Bishop MR, Park JH, DeAngelo DJ, Tholouli E, Yallop D, Chaganti S, Hodby K, Barba P, Guerreiro M, Menne T, Shang J, Lao-Sirieix P, Brugger W, Roddie C. Tumor burden-guided dosing contributes to mitigation of immunotoxicities following treatment with obecabtagene autoleucel in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. Haematologica. 2026 Jun 1;111(6):1999-2010. doi: 10.3324/haematol.2025.288587. Epub 2026 Jan 8.
- pmid
- 41504229
- type
- DERIVED
- citation
- Roddie C, Sandhu KS, Tholouli E, Logan AC, Shaughnessy P, Barba P, Ghobadi A, Guerreiro M, Yallop D, Abedi M, Pantin JM, Yared JA, Beitinjaneh AM, Chaganti S, Hodby K, Menne T, Arellano ML, Malladi R, Shah BD, Mountjoy L, O'Dwyer KM, Peggs KS, Lao-Sirieix P, Zhang Y, Brugger W, Braendle E, Pule M, Bishop MR, DeAngelo DJ, Park JH, Jabbour E. Obecabtagene Autoleucel in Adults with B-Cell Acute Lymphoblastic Leukemia. N Engl J Med. 2024 Dec 12;391(23):2219-2230. doi: 10.1056/NEJMoa2406526. Epub 2024 Nov 27.
- pmid
- 39602653
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- 14 CLINICAL STUDIES The efficacy of AUCATZYL was evaluated in an open-label, multi-center, single-arm study (FELIX study; NCT04404660). The study enrolled patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Eligible patients were adults with refractory ALL, first r
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Preserved source evidence · Not medical advice