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 — BIOLOGICAL
    No 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 therapy
    Patients 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)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-
Washington University in St. LouisSt LouisMissouri63110-
St David's South Austin Medical CenterAustinTexas78704-

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