Participant flow

Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma · Source last updated 2022-01-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.

   id

   FG000

   title

   GSK3377794

2. description

   Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.

   id

   FG001

   title

   GSK3377794+Pembrolizumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Long term follow-up declined, study terminated by sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 127 participants were screened of which 6 participants were enrolled in the study. The study was terminated due to challenging screening and enrollment combined with a rapidly changing treatment landscape.

recruitment Details

This was a pilot study to assess safety and tolerability of genetically engineered New York esophageal squamous cell carcinoma 1 (NY-ESO-1) (c259) T Cells Alone or in combination with pembrolizumab in participants with relapsed/refractory multiple myeloma. The study was conducted in the United States.

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Preserved source evidence · Not medical advice