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.

Phase 1

• Conditions: Relapsed or refractory B cell acute lymphoblastic leukaemia; MedDRA version: 21.0Level: LLTClassification code: 10000844Term: Acute lymphoblastic leukaemia Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512903-38-00
• Lead Sponsor: Autolus Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Age 18 years or older., Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., Relapsed or refractory CD19-positive B-ALL, Patients with Philadelphia chromosome positive ALL (Ph+ ALL) are eligible if they are intolerant to or have failed two lines of any tyrosine kinase inhibitor (TKI) or one line of second-generation TKI, or if TKI therapy is contraindicated., In patients treated with blinatumomab, CD19 expression should be confirmed after blinatumomab therapy has been stopped., Adequate renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria

Diagnosis of Burkitt’s leukaemia/lymphoma according to World Health Organisation (WHO) classification or chronic myelogenous leukaemia lymphoid in blast crisis., History or presence of clinically relevant CNS pathology, Presence of CNS 3 disease or CNS 2 disease with neurological changes, Active or latent Hepatitis B or active Hepatitis C.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the safety of AUTO1.<br>- To evaluate the clinical efficacy of AUTO1.;Secondary Objective: To evaluate the clinical efficacy of AUTO1., To assess the safety and tolerability of AUTO1., To evaluate the feasibility of manufacturing and administering AUTO1., To evaluate the expansion and persistence of AUTO1., To evaluate the duration of B cell aplasia.;Primary end point(s): Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion., Cohort IIA: Overall complete remission rate (ORR) defined as proportion of patients achieving CR or CRi as assessed by an Independent Response Review Committee (IRRC). Cohort IIB: Proportion of patients achieving MRD-negative remission by central ClonoSEQ NGS testing (<10-4 leukaemic cells)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Complete Remission Rate (CRR). CRR within 3 months post AUTO1 infusion. Proportion of patients achieving MRD-negative remission by central ClonoSEQ NGS testing (<10-4 leukaemic cells), PCR and/or flow cytometry. Duration of remission (DOR). Duration of complete remission (DOCR). Event free survival (EFS). Progression free survival (PFS). Overall survival (OS). ORR [CR+CRi] as assessed by the Investigator.;Secondary end point(s):Frequency and severity of AEs and SAEs. Incidence and duration of severe hypogammaglobulinaemia.;Secondary end point(s):Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered.;Secondary end point(s):Detection of CAR T cells measured by PCR in the peripheral blood and BM following AUTO1 infusion.;Secondary end point(s):Depletion of circulating B cells assessed by flow cytometry in the peripheral blood.