Follow-Up for Study Participants Treated With an Allogeneic CAR T-Cell Product

Long Term Follow up Study for Participants Treated With an Allogeneic CAR T-Cell Product in a Prior Clinical Study

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06925685

Enrollment

Registered

2025-04-13

Start date

2025-01-31

Completion date

2039-01-31

Last updated

2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies, Solid Tumors

Keywords

CAR T, Allogeneic CAR T, long term follow up

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results