Long-term follow-up of patients previously treated with an Autolus CAR T cell therapy

Long-term follow-up of patients previously treated with autologous T cells genetically modified with viral vectors.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004867-38-GB

Enrollment

500

Registered

2017-12-06

Start date

2018-05-18

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Potential malignancy in patients who received treatment with Autolus' CAR T cell therapy.

Interventions

Product Name: AUTO2 Product Code: AUTO2 Pharmaceutical Form: Dispersion for infusion INN or Proposed INN: n/a CAS Number: n/a Current Sponsor code: AUTO2 Other descriptive name: AUTOLOGOUS T-LYMPHOCYT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Patients must have received an AUTO CAR T cell therapy on a clinical treatment study. •Patients must have provided informed consent for long-term follow-up study prior to participation. •Patients must be able to comply with the study requirements. Are the trial subjects under 18? yes Number of subjects for this age range: 39 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 169 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 292

Exclusion criteria

Exclusion criteria: - There are no specific exclusion criteria for this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: Long-term safety. ;Secondary Objective: Survival. Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression Chimeric antigen receptor (CAR) transgene persistence Replication competent lentivirus (RCL) or retrovirus (RCR). emergence Insertional mutagenesis;Primary end point(s): •Incidence of serious adverse events •New malignancies •Other designated adverse events of special interest;Timepoint(s) of evaluation of this end point: After first Autolus' CAR T dose, Every 3 months up to year 1, every 6 months from year 2-5 and yearly from year 6-15.	—

Measure

Time frame

Main Objective: Long-term safety. ;Secondary Objective: Survival. Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression Chimeric antigen receptor (CAR) transgene persistence Replication competent lentivirus (RCL) or retrovirus (RCR). emergence Insertional mutagenesis;Primary end point(s): •Incidence of serious adverse events •New malignancies •Other designated adverse events of special interest;Timepoint(s) of evaluation of this end point: After first Autolus' CAR T dose, Every 3 months up to year 1, every 6 months from year 2-5 and yearly from year 6-15.

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Secondary

Measure	Time frame
Secondary end point(s): Overall survival Duration of response, progression-free survival Proportion of patients with detectable vector copy number Monitor for potential RCR Insertion site analysis in case of new malignancy;Timepoint(s) of evaluation of this end point: Throughout various time point in this study.	—

Countries

Netherlands, Spain, United Kingdom, United States

Contacts

Public ContactClinical Project Manager

Autolus Limited

clinicaltrials@autolus.com4402038296230

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026