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NCT03277729 · OUTCOME

Dose-limiting Toxicities (DLT) Rate

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 28 days

What was measured

Will be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.

Groups in this outcome

Dose Level 0 of CD20 CAR T Cells

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

Dose Level 1 of CD20 CAR T Cells

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

Dose Level 2 of CD20 CAR T Cells

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

Dose Level 3 of CD20 CAR-T Cells

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

Dose Level 4 of CD20 CAR-T Cells

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Level 0 of CD20 CAR T Cells1
Dose Level 1 of CD20 CAR T Cells8
Dose Level 2 of CD20 CAR T Cells4
Dose Level 3 of CD20 CAR-T Cells6
Dose Level 4 of CD20 CAR-T Cells31

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 0 of CD20 CAR T Cells0Not reportedNot reportedNot reportedNot reported
Dose Level 1 of CD20 CAR T Cells0Not reportedNot reportedNot reportedNot reported
Dose Level 2 of CD20 CAR T Cells0Not reportedNot reportedNot reportedNot reported
Dose Level 3 of CD20 CAR-T Cells0Not reportedNot reportedNot reportedNot reported
Dose Level 4 of CD20 CAR-T Cells0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      31
    units
    Participants
description
Will be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    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
    OG004
    title
    Dose Level 4 of CD20 CAR-T Cells
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 28 days
title
Dose-limiting Toxicities (DLT) Rate
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice