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NCT03590574 · OUTCOME

Duration of TRBC1 Positive T Cell Aplasia.

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
Cells/microL
Interval / dispersion
Full Range
Time frame
Up to 24 months

What was measured

Enumeration of circulating T cell receptor beta constant 1 positive T cells assessed by flow cytometry at a range of time points in the peripheral blood.

Analysis population: The number analyzed differs from overall number analyzed in some instances because patients died, withdrew of no longer participated in the study for other reasons.

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

Total

All patients infused

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
Total15

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 12
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
Total14
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 128.0Not reported2333Not reported
Phase I Dose Escalation - Cohort 240.0Not reported1268Not reported
Phase I Dose Escalation - Cohort 365.0Not reported6565Not reported
Phase I Dose Escalation - Cohort 43.5Not reported1843Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 33.0Not reported33Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 41.0Not reported14Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5316.0Not reported316316Not reported
Total8.0Not reported1843Not reported
Day 1

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 12
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
Total14
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 160.0Not reported2496Not reported
Phase I Dose Escalation - Cohort 298.5Not reported17180Not reported
Phase I Dose Escalation - Cohort 311.0Not reported1111Not reported
Phase I Dose Escalation - Cohort 43.5Not reported1555Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 31.0Not reported11Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 47.0Not reported328Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 513.0Not reported1313Not reported
Total20.0Not reported3148Not reported
Day 14

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 12
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
Total14
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 1103.0Not reported96110Not reported
Phase I Dose Escalation - Cohort 284.5Not reported21148Not reported
Phase I Dose Escalation - Cohort 323.0Not reported2323Not reported
Phase I Dose Escalation - Cohort 47.0Not reported77Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 314.0Not reported522Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 47.0Not reported328Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 513.0Not reported1313Not reported
Total20.0Not reported3148Not reported
Day 28

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 12
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 50
Total13
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 178.0Not reported22134Not reported
Phase I Dose Escalation - Cohort 2306.0Not reported291321Not reported
Phase I Dose Escalation - Cohort 356.0Not reported5656Not reported
Phase I Dose Escalation - Cohort 418.5Not reported2134Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 338.0Not reported3838Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 415.0Not reported533Not reported
Total33.0Not reported2321Not reported
Month 3

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 11
Phase I Dose Escalation - Cohort 21
Phase I Dose Escalation - Cohort 31
Phase I Dose Escalation - Cohort 44
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 30
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 41
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 50
Total8
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 1193.0Not reported193193Not reported
Phase I Dose Escalation - Cohort 2173.0Not reported173173Not reported
Phase I Dose Escalation - Cohort 341.0Not reported4141Not reported
Phase I Dose Escalation - Cohort 426.5Not reported782Not reported
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 40.0Not reported00Not reported
Total41.0Not reported0193Not reported
Month 6

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 10
Phase I Dose Escalation - Cohort 21
Phase I Dose Escalation - Cohort 31
Phase I Dose Escalation - Cohort 41
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 30
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 40
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 50
Total3
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 229.0Not reported2929Not reported
Phase I Dose Escalation - Cohort 320.0Not reported2020Not reported
Phase I Dose Escalation - Cohort 429.0Not reported2929Not reported
Total29Not reported2029Not reported
Month 9

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 10
Phase I Dose Escalation - Cohort 20
Phase I Dose Escalation - Cohort 30
Phase I Dose Escalation - Cohort 43
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 30
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 40
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 50
Total3
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 420.0Not reported1132Not reported
Total20.0Not reported1132Not reported
Month 12

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 10
Phase I Dose Escalation - Cohort 20
Phase I Dose Escalation - Cohort 30
Phase I Dose Escalation - Cohort 43
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 30
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 40
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 50
Total3
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 449.0Not reported8101Not reported
Total49.0Not reported8101Not reported
Month 18

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 10
Phase I Dose Escalation - Cohort 20
Phase I Dose Escalation - Cohort 30
Phase I Dose Escalation - Cohort 43
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 30
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 40
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 50
Total3
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 438.0Not reported27177Not reported
Total38.0Not reported27177Not reported
Month 24

Analysis denominator · Participants

GroupSource count
Phase I Dose Escalation - Cohort 10
Phase I Dose Escalation - Cohort 21
Phase I Dose Escalation - Cohort 30
Phase I Dose Escalation - Cohort 40
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 30
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 40
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 50
Total1
Values in Cells/microL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Dose Escalation - Cohort 261.0Not reported6161Not reported
Total61.0Not reported6161Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23
        upper Limit
        33
        value
        28.0
      2. group Id
        OG001
        lower Limit
        12
        upper Limit
        68
        value
        40.0
      3. group Id
        OG002
        lower Limit
        65
        upper Limit
        65
        value
        65.0
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        843
        value
        3.5
      5. group Id
        OG004
        lower Limit
        3
        upper Limit
        3
        value
        3.0
      6. group Id
        OG005
        lower Limit
        1
        upper Limit
        4
        value
        1.0
      7. group Id
        OG006
        lower Limit
        316
        upper Limit
        316
        value
        316.0
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        843
        value
        8.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      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
      8. group Id
        OG007
        value
        14
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24
        upper Limit
        96
        value
        60.0
      2. group Id
        OG001
        lower Limit
        17
        upper Limit
        180
        value
        98.5
      3. group Id
        OG002
        lower Limit
        11
        upper Limit
        11
        value
        11.0
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        555
        value
        3.5
      5. group Id
        OG004
        lower Limit
        1
        upper Limit
        1
        value
        1.0
      6. group Id
        OG005
        lower Limit
        3
        upper Limit
        28
        value
        7.0
      7. group Id
        OG006
        lower Limit
        13
        upper Limit
        13
        value
        13.0
      8. group Id
        OG007
        lower Limit
        3
        upper Limit
        148
        value
        20.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      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
      8. group Id
        OG007
        value
        14
      units
      Participants
    title
    Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        96
        upper Limit
        110
        value
        103.0
      2. group Id
        OG001
        lower Limit
        21
        upper Limit
        148
        value
        84.5
      3. group Id
        OG002
        lower Limit
        23
        upper Limit
        23
        value
        23.0
      4. group Id
        OG003
        lower Limit
        7
        upper Limit
        7
        value
        7.0
      5. group Id
        OG004
        lower Limit
        5
        upper Limit
        22
        value
        14.0
      6. group Id
        OG005
        lower Limit
        3
        upper Limit
        28
        value
        7.0
      7. group Id
        OG006
        lower Limit
        13
        upper Limit
        13
        value
        13.0
      8. group Id
        OG007
        lower Limit
        3
        upper Limit
        148
        value
        20.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      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
      8. group Id
        OG007
        value
        14
      units
      Participants
    title
    Day 14
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        134
        value
        78.0
      2. group Id
        OG001
        lower Limit
        291
        upper Limit
        321
        value
        306.0
      3. group Id
        OG002
        lower Limit
        56
        upper Limit
        56
        value
        56.0
      4. group Id
        OG003
        lower Limit
        2
        upper Limit
        134
        value
        18.5
      5. group Id
        OG004
        lower Limit
        38
        upper Limit
        38
        value
        38.0
      6. group Id
        OG005
        lower Limit
        5
        upper Limit
        33
        value
        15.0
      7. group Id
        OG007
        lower Limit
        2
        upper Limit
        321
        value
        33.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      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
        0
      8. group Id
        OG007
        value
        13
      units
      Participants
    title
    Day 28
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        193
        upper Limit
        193
        value
        193.0
      2. group Id
        OG001
        lower Limit
        173
        upper Limit
        173
        value
        173.0
      3. group Id
        OG002
        lower Limit
        41
        upper Limit
        41
        value
        41.0
      4. group Id
        OG003
        lower Limit
        7
        upper Limit
        82
        value
        26.5
      5. group Id
        OG005
        lower Limit
        0
        upper Limit
        0
        value
        0.0
      6. group Id
        OG007
        lower Limit
        0
        upper Limit
        193
        value
        41.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        8
      units
      Participants
    title
    Month 3
  6. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        29
        upper Limit
        29
        value
        29.0
      2. group Id
        OG002
        lower Limit
        20
        upper Limit
        20
        value
        20.0
      3. group Id
        OG003
        lower Limit
        29
        upper Limit
        29
        value
        29.0
      4. group Id
        OG007
        lower Limit
        20
        upper Limit
        29
        value
        29
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        3
      units
      Participants
    title
    Month 6
  7. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        11
        upper Limit
        32
        value
        20.0
      2. group Id
        OG007
        lower Limit
        11
        upper Limit
        32
        value
        20.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        3
      units
      Participants
    title
    Month 9
  8. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        8
        upper Limit
        101
        value
        49.0
      2. group Id
        OG007
        lower Limit
        8
        upper Limit
        101
        value
        49.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        3
      units
      Participants
    title
    Month 12
  9. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        27
        upper Limit
        177
        value
        38.0
      2. group Id
        OG007
        lower Limit
        27
        upper Limit
        177
        value
        38.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        3
      units
      Participants
    title
    Month 18
  10. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        61
        upper Limit
        61
        value
        61.0
      2. group Id
        OG007
        lower Limit
        61
        upper Limit
        61
        value
        61.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      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
        0
      8. group Id
        OG007
        value
        1
      units
      Participants
    title
    Month 24
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
    8. group Id
      OG007
      value
      15
    units
    Participants
description
Enumeration of circulating T cell receptor beta constant 1 positive T cells assessed by flow cytometry at a range of time points in the peripheral blood.
dispersion Type
Full Range
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
  8. description
    All patients infused
    id
    OG007
    title
    Total
param Type
MEDIAN
population Description
The number analyzed differs from overall number analyzed in some instances because patients died, withdrew of no longer participated in the study for other reasons.
reporting Status
POSTED
time Frame
Up to 24 months
title
Duration of TRBC1 Positive T Cell Aplasia.
type
SECONDARY
unit Of Measure
Cells/microL

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Preserved source evidence · Not medical advice