ong-term follow-up of patients previously treated with an Autolus CAR T cell therapy
Phase 1
- Conditions
- Potential malignancy in patients who received treatment with Autolus' CAR T cell therapy.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004867-38-GB
- Lead Sponsor
- Autolus Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 500
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
- There are no specific exclusion criteria for this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Long-term safety.<br>;Secondary Objective: Survival.<br>Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression<br>Chimeric antigen receptor (CAR) transgene persistence<br>Replication competent lentivirus (RCL) or retrovirus (RCR). emergence<br>Insertional mutagenesis;Primary end point(s): •Incidence of serious adverse events<br>•New malignancies<br>•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.<br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival<br>Duration of response, progression-free survival<br>Proportion of patients with detectable vector copy number<br>Monitor for potential RCR <br>Insertion site analysis in case of new malignancy;Timepoint(s) of evaluation of this end point: Throughout various time point in this study.