NCT06925685

Brief Summary

An observational, long-term follow up (LTFU) study of participants who received an allogeneic CAR T product in a prior clinical study. Participants will be followed for 15 years after their last infusion of an allogenic CAR T cell product.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
154mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress9%
Jan 2025Jan 2039

Study Start

First participant enrolled

January 31, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2039

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2039

Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

13.9 years

First QC Date

April 7, 2025

Last Update Submit

April 7, 2025

Conditions

Hematologic MalignanciesSolid Tumors

Keywords

CAR TAllogeneic CAR Tlong term follow up

Outcome Measures

Primary Outcomes (3)

  • Incidence of delayed adverse events potentially related to allogeneic CAR T-cell product and allogeneic CAR T-cell product-related SAEs

    Up to 15 years post treatment with allogeneic CAR T-cell product

  • Overall survival (OS)

    Up to 15 years post treatment with allogeneic CAR T cell product

  • Presence of replication competent lentivirus (RCL) in blood

    Up to 15 years post treatment with allogeneic CAR T cell product

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who have received an allogeneic CAR T-cell product.

You may qualify if:

  • Received an allogenic CAR T-cell product infusion to treat an oncologic condition in a previous Allogene or Servier sponsored clinical study

You may not qualify if:

  • Less than 12 months of follow up after the last allogeneic CAR T-cell product, unless approved by the Allogene Medical Monitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Circuit Clinical

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Allogene Study Director

    Allogene Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 13, 2025

Study Start

January 31, 2025

Primary Completion (Estimated)

January 1, 2039

Study Completion (Estimated)

January 1, 2039

Last Updated

April 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)