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AUTO1

Phase 1

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia | Monoclonal antibody | Oncology |Autolus Therapeutics plc|Last Updated: Apr 8, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment183

FDA Designations

No designations recorded

Clinical trial landscape

AUTO1 · 2 trials · 2 indications

Phase 1 2
NCT06173518A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
RECRUITING30 Analytics
NCT04404660A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
ACTIVE NOT_RECRUITING153 Analytics
PHASE1RECRUITING
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaUnlock trial analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Up to 24 months
Incidence and duration of severe hypogammaglobulinemia
Up to 24 months
Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment
3 months
Phase 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
Up to 24 months
Phase 2 - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC.
Up to 24 months

Secondary Endpoints

CR per IRRC assessment at any time in B ALL
Up to 24 months
Overall remission rate (ORR) (CR + complete remission with incomplete recovery of counts [CRi]) per IRRC assessment at any time in B ALL
Up to 24 months
Minimal residual disease (MRD)-negative ORR per IRRC assessment at any time in B ALL
Up to 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AUTO1EXPERIMENTAL -

Interventions

NameTypeDescription
AUTO1BIOLOGICALFollowing lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells
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Eligibility Criteria

Age Range0 Years to 18 Years
SexALL
Healthy VolunteersNo
Study Sites8

INCLUSION CRITERIA: * \< 18 years old at screening * ≥ 6 kg body weight at screening Pediatric patients with r/r B ALL r/r CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) ...

Countries:United StatesSpainUnited Kingdom
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Frequently asked questions about AUTO1

What is AUTO1 used for?

AUTO1 is an investigational CD19-targeted CAR T cell therapy being studied for relapsed or refractory B cell acute lymphoblastic leukemia (ALL). It is also being evaluated in pediatric patients with relapsed or refractory B cell ALL and aggressive mature B-cell non-Hodgkin lymphoma (B NHL). The drug is in Phase 1 clinical development.

What does AUTO1 target?

AUTO1 targets CD19, a protein found on B cells. As a CD19-targeted CAR T cell therapy, it is designed to recognize and attack CD19-expressing cancer cells in patients with B cell malignancies, including relapsed or refractory B cell acute lymphoblastic leukemia.

Who makes AUTO1?

AUTO1 is being developed by Autolus Therapeutics plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol AUTL. The company is conducting clinical trials of AUTO1 in adult and pediatric patients with B cell acute lymphoblastic leukemia and related B cell malignancies.

What phase is AUTO1 in?

AUTO1 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. Two Phase 1 trials are currently active, one in adult patients and one in pediatric patients with relapsed or refractory B cell malignancies.

What clinical trials is AUTO1 in?

AUTO1 is being studied in two Phase 1 clinical trials. NCT04404660 is an active, not recruiting study in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, with 153 participants. NCT06173518 is a recruiting study in pediatric patients with relapsed or refractory B cell ALL and B cell non-Hodgkin lymphoma, with 30 participants.

Is AUTO1 the same as a CD19 CAR T cell therapy?

Yes, AUTO1 is a CD19-targeted CAR T cell therapy. It is designed to target CD19 on B cells and is being investigated for the treatment of relapsed or refractory B cell acute lymphoblastic leukemia and other B cell malignancies in both adult and pediatric patients.