Participant flow

MAGE-A4ᶜ¹º³²T for Multi-Tumor · Source last updated 2026-06-04

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

groups

1. description

   Participants who received afamitresgene autoleucel 0.1x10\^9 (±20%) transduced cells

   id

   FG000

   title

   Afamitresgene Autoleucel, Group 1

2. description

   Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells

   id

   FG001

   title

   Afamitresgene Autoleucel, Group 2

3. description

   Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells

   id

   FG002

   title

   Afamitresgene Autoleucel, Group 3 + Expansion

4. description

   Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\^9 transduced cells).

   id

   FG003

   title

   Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         0

      type

      Ongoing in Interventional phase at data cut-off (1Sep2020)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         32

      4. group Id

         FG003

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         32

      4. group Id

         FG003

         num Subjects

         4

      type

      Received Afamitresgene Autoleucel

   3. achievements

      1. comment

         1completed = discontinued from the Interventional phase

         group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         29

      4. group Id

         FG003

         num Subjects

         4

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The main study could enroll up to 18 participants in the dose escalation phase (data cut off 01Sep2020). Following the dose escalation phase, the study was expanded to enroll up to approximately 30 participants at the selected dose range (inclusive of those treated during dose escalation at that dose range) across all the eligible tumor types to better characterize and assess overall safety. The sub study planned to enroll up to 10 participants (data cut off 13Jan2022).

recruitment Details

This was an open-label Phase 1 dose escalation study of afamitresgene autoleucel in HLA-A\*02 positive participants with MAGE-A4 expressing unresectable locally advanced or metastatic cancer of the following types: urothelial, melanoma, head and neck, ovarian, NSCLC, esophageal (squamous and adenocarcinoma), gastric, synovial sarcoma, or MRCLS. This study had a substudy component that investigated the safety and tolerability of afamitresgene autoleucel in combination with low dose radiation.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice