NCT06825845

Brief Summary

This is a prospective long-term follow-up (LTFU) study to evaluate the long-term safety and survival benefit for patients who received at least one of CARsgen's GM T cell product in a clinical trial or as a commercially available product. In this study, patients will be followed for up to 15 years after last GM T-cell infusion for the evaluation of delayed adverse events (AEs), vector persistence, potential risk for integration, and survival time due to GM T-cell exposure.

Trial Health

65
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Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
173mo left

Started Mar 2025

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2025Jun 2040

First Submitted

Initial submission to the registry

February 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2039

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2040

Last Updated

February 13, 2025

Status Verified

January 1, 2025

Enrollment Period

14.8 years

First QC Date

February 8, 2025

Last Update Submit

February 8, 2025

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • To assess the risk of delayed AEs following exposure to GM T cells

    15 years

Interventions

Zevorcabtagene AutoleucelDRUG

Non-intervention

Eligibility Criteria

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

Before any study procedure, informed consent must be signed by the participants, or by the participant's legal guardian for patients with no full civil capacity

You may qualify if:

  • \- 1. All patients who have received at least one GM T-cell infusion in the parent clinical study or in the post-approval setting.
  • \. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For patients incapable of providing consent, the signed ICF of their legally accepted guardians must be obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

RecurrenceMultiple Myeloma

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Yajing Zhang

CONTACT

1860133385623975701@qq.com

Study Design

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

Study Record Dates

First Submitted

February 8, 2025

First Posted

February 13, 2025

Study Start

March 31, 2025

Primary Completion (Estimated)

December 31, 2039

Study Completion (Estimated)

June 30, 2040

Last Updated

February 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share