Participant flow

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas · Source last updated 2026-06-22

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

groups

1. description

   Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV

   id

   FG000

   title

   Dose Level 0 of CD20 CAR T Cells

2. description

   Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV

   id

   FG001

   title

   Dose Level 1 of CD20 CAR T Cells

3. description

   Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV

   id

   FG002

   title

   Dose Level 2 of CD20 CAR T Cells

4. description

   Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV

   id

   FG003

   title

   Dose Level 3 of CD20 CAR-T Cells

5. description

   Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV

   id

   FG004

   title

   Dose Level 4 of CD20 CAR-T Cells

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         31

      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

         5

      5. group Id

         FG004

         num Subjects

         20

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Fifty-three participants were enrolled but three participants did not move on to treatment due to worsening of their disease status. They were not assigned to a treatment dose level.

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

Preserved source evidence · Not medical advice