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A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404660
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Autolus Limited

Brief Summary:
This is a Phase Ib/II 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 B cell acute lymphoblastic leukemia (ALL).

Condition or disease Intervention/treatment Phase
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Biological: AUTO1 Phase 1 Phase 2

Detailed Description:

This Phase Ib/II, 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 relapsed or refractory 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
Experimental: AUTO1 Biological: AUTO1
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).




Primary Outcome Measures :
  1. Phase Ib - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion [ Time Frame: Up to 24 months ]
  2. Phase II - Overall response rate (ORR) defined as best response of complete response (CR) or complete response with incomplete recovery of counts (CRi) occurring at any time after AUTO1 infusion [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Phase II - Response to AUTO1 treatment measured as duration of response (DOR) [ Time Frame: Up to 24 months ]
  2. Phase II - Response to AUTO1 measured as progression-free survival (PFS). [ Time Frame: Up to 24 months ]
  3. Phase II -Response to AUTO1 treatment measured as overall survival (OS) [ Time Frame: Up to 24 months ]
  4. Phase II - Frequency and severity of AEs and SAEs [ Time Frame: Up to 24 months ]
  5. Phase II - Incidence of severe hypogammaglobulinaemia [ Time Frame: Up to 24 months ]
  6. Phase II - Duration of severe hypogammaglobulinaemia [ Time Frame: Up to 24 months ]
  7. Phase II - Detection of CAR T cells measured by PCR following AUTO1 infusion [ Time Frame: Up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older 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 Ib: Presence of ≥5% blasts in BM at screening
  • Phase II: Cohort A: Presence of ≥5% blasts in BM at screening
  • Phase II: Cohort B: MRD-positive defined as ≥1E-4 and <5% blasts in the BM at screening
  • Adequate renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

  • Phase Ib and Phase II Cohort A only 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404660


Contacts
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Contact: Autolus Limited +44 (0)203 911 4385 Clinicaltrials@autolus.com

Locations
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Sponsors and Collaborators
Autolus Limited
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Responsible Party: Autolus Limited
ClinicalTrials.gov Identifier: NCT04404660    
Other Study ID Numbers: AUTO1-AL1
2019-001937-16 ( EudraCT Number )
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Autolus Limited:
B cell acute lymphoblastic leukemia
Relapsed B cell acute lymphoblastic leukemia
Refractory B cell acute lymphoblastic leukemia
ALL
AUTO1
CD19-positive CAR T cell
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases