Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Autolus Limited
- Study ID
- NCT03628612
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- ALL, Adult and Pediatric
- DLBCL
- Multiple Myeloma
- Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy
- T Cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AUTO CAR T cell therapy — BIOLOGICALNo study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.
Study Details
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
Key Dates
- Start date
- Aug 2, 2018
- Status verified
- Aug 2025
- Primary completion
- Jul 31, 2043
- Completion
- Dec 31, 2043
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: AUTO CAR T cell therapyPatients who received previous treatment with AUTO CAR T Cell Therapy
Primary Outcome Measure
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy [ Time Frame: For up to 15 years ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | - |
| Washington University in St. Louis | St Louis | Missouri | 63110 | - |
| St David's South Austin Medical Center | Austin | Texas | 78704 | - |
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