Long-Term Follow-Up (LTFU) of Participants Treated with Adoptive Cell Therapies

Conditions

Multiple Myeloma & other indications, Myxoid/round cell liposarcoma (MRCLS), Non-small cell lung cancer (NSCLC), Synovial sarcoma

Brief summary

AEs/SAEs to be reported: New malignancies, AEs/SAEs to be reported: New incidence or exacerbation of a pre-existing neurologic disorder, AEs/SAEs to be reported: New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, AEs/SAEs to be reported: New incidence of hematologic disorder, AEs/SAEs to be reported: New incidence of infection (potentially related to gene modified cell therapy), AEs/SAEs to be reported: Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy

Detailed description

Vesicular Stomatitis Virus G protein (VSV-G) deoxyribonucleic acid (DNA) copies in peripheral blood samples., Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples, Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) identified in peripheral blood, Incidence of death and time to death

Related papers

No related papers found yet.

Interventions

DRUGGSK3377794

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AEs/SAEs to be reported: New malignancies, AEs/SAEs to be reported: New incidence or exacerbation of a pre-existing neurologic disorder, AEs/SAEs to be reported: New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, AEs/SAEs to be reported: New incidence of hematologic disorder, AEs/SAEs to be reported: New incidence of infection (potentially related to gene modified cell therapy), AEs/SAEs to be reported: Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy	—

Measure

Time frame

AEs/SAEs to be reported: New malignancies, AEs/SAEs to be reported: New incidence or exacerbation of a pre-existing neurologic disorder, AEs/SAEs to be reported: New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, AEs/SAEs to be reported: New incidence of hematologic disorder, AEs/SAEs to be reported: New incidence of infection (potentially related to gene modified cell therapy), AEs/SAEs to be reported: Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy

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Secondary

Measure	Time frame
Vesicular Stomatitis Virus G protein (VSV-G) deoxyribonucleic acid (DNA) copies in peripheral blood samples., Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples, Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) identified in peripheral blood, Incidence of death and time to death	—