NCT03628612

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
213mo left

Started Aug 2018

Longer than P75 for phase_2

Geographic Reach
2 countries

8 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Aug 2018Dec 2043

First Submitted

Initial submission to the registry

July 7, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
24.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2043

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2043

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

24.9 years

First QC Date

July 7, 2018

Last Update Submit

August 4, 2025

Conditions

Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell TherapyMultiple MyelomaDLBCLALL, Adult and PediatricT Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy

    Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy. Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion.

    For up to 15 years

Secondary Outcomes (7)

  • Overall Survival following first AUTO CAR T cell therapy infusion.

    Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15

  • Duration of supportive care

    Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15

  • Duration of response

    Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15

  • Progression-free survival

    Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15

  • Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion

    For up to 15 years

  • +2 more secondary outcomes

Study Arms (1)

AUTO CAR T cell therapy

EXPERIMENTAL

Patients who received previous treatment with AUTO CAR T Cell Therapy

Biological: AUTO CAR T cell therapy

Interventions

AUTO CAR T cell therapyBIOLOGICAL

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.

AUTO CAR T cell therapy

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Miami

Miami, Florida, 33136, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

St David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Location

Manchester Royal Infirmary Hospital

Manchester, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, United Kingdom

Location

Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Multiple MyelomaLymphoma, T-Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphomaLymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2018

First Posted

August 14, 2018

Study Start

August 2, 2018

Primary Completion (Estimated)

July 1, 2043

Study Completion (Estimated)

December 1, 2043

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(5)US(3)