Participant flow

Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma · Source last updated 2026-03-16

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

groups

1. description

   Patients received 25x10\^6 Ritux-QBEND/10-Ritux-CD8 sort-suicide gene generated as a marker/suicide gene for T cells (RQR8)/anti-T cell receptor beta constant (aTRBC)1 chimeric antigen receptor (CAR) T-positive cells

   id

   FG000

   title

   Phase I Dose Escalation - Cohort 1

2. description

   Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells

   id

   FG001

   title

   Phase I Dose Escalation - Cohort 2

3. description

   Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells

   id

   FG002

   title

   Phase I Dose Escalation - Cohort 3

4. description

   Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells

   id

   FG003

   title

   Phase I Dose Escalation - Cohort 4

5. description

   Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells

   id

   FG004

   title

   Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3

6. description

   Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells

   id

   FG005

   title

   Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4

7. description

   Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells

   id

   FG006

   title

   Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5

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

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         0

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      Patient decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      Disease progression

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         1

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Twenty patients were enrolled and AUTO4 was manufactured using leukapheresed autologous peripheral blood mononuclear cells. Five patients did not receive AUTO4 infusion. This was due to death in 2 patients, achieving remission with other chemotherapy (1 patient), central nervous system involvement (1 patient) and proceeding to stem cell transplant (1 patient).

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Preserved source evidence · Not medical advice