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NCT03590574 · OUTCOME

Frequency of Dose-limiting Toxicity (DLT) of AUTO4 Within 28 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
28 days of AUTO4 infusion

What was measured

To identify the recommended Phase II dose and maximum tolerated dose (MTD), if an MTD exists, of AUTO4 by monitoring the frequency of DLT of AUTO4 within 28 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 10Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation - Cohort 20Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation - Cohort 30Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation - Cohort 40Not reportedNot reportedNot reportedNot reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 30Not 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
        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
      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 identify the recommended Phase II dose and maximum tolerated dose (MTD), if an MTD exists, of AUTO4 by monitoring the frequency of DLT of AUTO4 within 28 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
28 days of AUTO4 infusion
title
Frequency of Dose-limiting Toxicity (DLT) of AUTO4 Within 28 Days of AUTO4 Infusion.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice