Clinical trial · Observational

Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy

NCT06825845CI-TRIAL-00085921not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Relapsed or Refractory Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Zevorcabtagene Autoleucel	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
To assess the risk of delayed AEs following exposure to GM T cells
timeFrame
15 years

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

\- 1. All patients who have received at least one GM T-cell infusion in the parent clinical study or in the post-approval setting.

2\. 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.

Exclusion Criteria:

* There are no specific exclusion criteria for this study.

References

Publications (0)

Data not yet available

No reference posted for this study.