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NCT03590574 · OUTCOME

The Numbers of Patients With Grade 3 to 5 Toxicity Occurring Within 60 Days of AUTO4 Infusion.

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
60 days of AUTO4 infusion

What was measured

To assess the safety and tolerability of AUTO4 administration. The incidence of Grade 3-5 toxicities occurring within 60 days of AUTO4 infusion.

Groups in this outcome

Phase I Dose Escalation - Cohort 1

Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells

Phase I Dose Escalation - Cohort 2

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

Phase I Dose Escalation - Cohort 3

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

Phase I Dose Escalation - Cohort 4

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

Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3

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

Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4

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

Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5

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

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

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 13
Phase I Dose Escalation - Cohort 22
Phase I Dose Escalation - Cohort 31
Phase I Dose Escalation - Cohort 44
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 31
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 43
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 51

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 13Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation - Cohort 22Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation - Cohort 31Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation - Cohort 44Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 31Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 40Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 51Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      1
    units
    Participants
description
To assess the safety and tolerability of AUTO4 administration. The incidence of Grade 3-5 toxicities occurring within 60 days of AUTO4 infusion.
groups
  1. description
    Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG000
    title
    Phase I Dose Escalation - Cohort 1
  2. description
    Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG001
    title
    Phase I Dose Escalation - Cohort 2
  3. description
    Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG002
    title
    Phase I Dose Escalation - Cohort 3
  4. description
    Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG003
    title
    Phase I Dose Escalation - Cohort 4
  5. description
    Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG004
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3
  6. description
    Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG005
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4
  7. description
    Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG006
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
60 days of AUTO4 infusion
title
The Numbers of Patients With Grade 3 to 5 Toxicity Occurring Within 60 Days of AUTO4 Infusion.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice