Clinical trial · Interventional
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
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
NCT04404660CI-TRIAL-00107567active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AUTO1 | Biological | Obecabtagene Autoleucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AUTO1
- interventionNames
- Biological: AUTO1
Primary outcomes (2)
- measure
- Phase 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
- timeFrame
- Up to 24 months
- measure
- Phase 2 - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC.
- timeFrame
- Up to 24 months
Secondary outcomes (9)
- measure
- Phase 2 - Proportion of patients achieving MRD-negative CR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDJabbour 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
- DERIVEDRoddie 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