Recurrent ovarian cancer positive for MAGE-A4 in human leukocyte antigen (HLA)-A2+ subjects
Conditions
Brief summary
The primary endpoint for efficacy is OR defined as complete response(CR) or partial response (PR) according to RECIST v1.1 by IRAC, from T-cell infusion until documented disease progression. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria of response are first met.
Detailed description
AEs, including SAEs, Incidence, severity, and duration of the adverse events of special interest (AESIs), Replication competent lentivirus (RCL), T-cell clonality and insertional oncogenesis (IO)
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
USWM Ct LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for efficacy is OR defined as complete response(CR) or partial response (PR) according to RECIST v1.1 by IRAC, from T-cell infusion until documented disease progression. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria of response are first met. | — |
Secondary
| Measure | Time frame |
|---|---|
| AEs, including SAEs, Incidence, severity, and duration of the adverse events of special interest (AESIs), Replication competent lentivirus (RCL), T-cell clonality and insertional oncogenesis (IO) | — |
Countries
France, Spain
Outcome results
None listed