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NCT03590574 · OUTCOME

Evaluate Progression-free Survival (PFS) Following Treatment With AUTO4.

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 24 months

What was measured

PFS was defined as the time from the first treatment of AUTO4 to documented disease progression/relapse or death due to any cause. If a patient did not have relapse or death due to any reason prior to data cut-off, PFS was censored at the date of the last adequate assessment by default. Patients who received protocol specified anti-cancer treatment post AUTO4 infusion were ignored in the main analysis. Patients who proceeded to SCT after AUTO4 infusion were censored at the time of SCT (including the conditioning regimen for SCT). Patients who received new non-protocol anticancer therapies other than SCT were censored as the date of last adequate assessment prior to the new therapy. Patients who experienced event after missing two or more scheduled disease assessments were censored at the date of last adequate assessment prior to the event

Analysis population: Data for PFS were pooled for analysis because the number of patients was \<5 for all of the groups and the intended reverse Kaplan-Meier model cannot be built with such a small sample size

Groups in this outcome

All Treated Patients Evaluable for PFS

All patients who received an infusion of AUTO4 and who were not censored.

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
All Treated Patients Evaluable for PFS15
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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Treated Patients Evaluable for PFS2.89Not reported0.956.54Not reported
Phase I Dose Escalation - Cohort 1NANot reportedNANAThe intended reverse Kaplan-Meier model could not be built with so few patients in the group.
Phase I Dose Escalation - Cohort 2NANot reportedNANAThe intended reverse Kaplan-Meier model could not be built with so few patients in the group.
Phase I Dose Escalation - Cohort 3NANot reportedNANAThe intended reverse Kaplan-Meier model could not be built with so few patients in the group.
Phase I Dose Escalation - Cohort 4NANot reportedNANAThe intended reverse Kaplan-Meier model could not be built with so few patients in the group.
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3NANot reportedNANAThe intended reverse Kaplan-Meier model could not be built with so few patients in the group.
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4NANot reportedNANAThe intended reverse Kaplan-Meier model could not be built with so few patients in the group.
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5NANot reportedNANAThe intended reverse Kaplan-Meier model could not be built with so few patients in the group.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.95
        upper Limit
        6.54
        value
        2.89
      2. comment
        The intended reverse Kaplan-Meier model could not be built with so few patients in the group.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        The intended reverse Kaplan-Meier model could not be built with so few patients in the group.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        The intended reverse Kaplan-Meier model could not be built with so few patients in the group.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        The intended reverse Kaplan-Meier model could not be built with so few patients in the group.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. comment
        The intended reverse Kaplan-Meier model could not be built with so few patients in the group.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      7. comment
        The intended reverse Kaplan-Meier model could not be built with so few patients in the group.
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      8. comment
        The intended reverse Kaplan-Meier model could not be built with so few patients in the group.
        group Id
        OG007
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      1
    units
    Participants
description
PFS was defined as the time from the first treatment of AUTO4 to documented disease progression/relapse or death due to any cause. If a patient did not have relapse or death due to any reason prior to data cut-off, PFS was censored at the date of the last adequate assessment by default. Patients who received protocol specified anti-cancer treatment post AUTO4 infusion were ignored in the main analysis. Patients who proceeded to SCT after AUTO4 infusion were censored at the time of SCT (including the conditioning regimen for SCT). Patients who received new non-protocol anticancer therapies other than SCT were censored as the date of last adequate assessment prior to the new therapy. Patients who experienced event after missing two or more scheduled disease assessments were censored at the date of last adequate assessment prior to the event
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients who received an infusion of AUTO4 and who were not censored.
    id
    OG000
    title
    All Treated Patients Evaluable for PFS
  2. description
    Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG001
    title
    Phase I Dose Escalation - Cohort 1
  3. description
    Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG002
    title
    Phase I Dose Escalation - Cohort 2
  4. description
    Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG003
    title
    Phase I Dose Escalation - Cohort 3
  5. description
    Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG004
    title
    Phase I Dose Escalation - Cohort 4
  6. description
    Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG005
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3
  7. description
    Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG006
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4
  8. description
    Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells
    id
    OG007
    title
    Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5
param Type
MEDIAN
population Description
Data for PFS were pooled for analysis because the number of patients was \<5 for all of the groups and the intended reverse Kaplan-Meier model cannot be built with such a small sample size
reporting Status
POSTED
time Frame
Up to 24 months
title
Evaluate Progression-free Survival (PFS) Following Treatment With AUTO4.
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice