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NCT05194735 · OUTCOME

TCR-T Cell Persistence

Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors · Source last updated 2025-11-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
copies/1x10^6 cells
Interval / dispersion
Full Range
Time frame
Baseline through Month 18 post-infusion.

What was measured

Persistence of TCR-T cells in peripheral blood was assessed by quantitative PCR for vector copy number per 1 × 10⁶ cells at baseline (1 week prior to infusion), predose (Day 0), and multiple post-infusion time points through Month 18. Only quantifiable values are summarized. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" are reported as NA and excluded from summary statistics.

Analysis population: Persistence analyses included the 8 participants who received TCR-T infusion (1 at Dose Level 1 and 7 at Dose Level 2). A total of 14 participants underwent apheresis, but only infused participants were evaluable for persistence. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" were not quantifiable and are reported as NA. Participants without samples at a given time point were excluded.

Groups in this outcome

Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)

Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.

Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)

Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.

Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)

Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.

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

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0

Reported measurements

Baseline (1 week prior to infusion)

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)NANot reportedNot reportedNot reportedValues listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)NANot reported00Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
Predose Day 0

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)6
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)NANot reportedNot reportedNot reportedValues listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)NANot reported00Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
Post Dose Day 0

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)6
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)4,240,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)2,570,000Not reported779,0003,970,000Not reported
Day 1

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)3,190,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)59,200Not reported20,7001,710,000Not reported
Day 2

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)2,640,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)408,000Not reported02,270,000Not reported
Day 4

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)3,500,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)570,000Not reported18,7003,400,000Not reported
Day 7

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)743,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)101,000Not reported5,3203,730,000Not reported
Day 10

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)674,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)112,000Not reported14,200961,000Not reported
Day 14

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)984,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)112,000Not reported7,900938,000Not reported
Day 21

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)504,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)41,300Not reported1,140489,000Not reported
Day 28

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)404,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)32,100Not reported0297,000Not reported
Week 6

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)197,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)27,800Not reported0203,000Not reported
Week 12

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)5
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)163,000Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)27,200Not reported1,960121,000Not reported
Month 3

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)0
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)1
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)42,400Not reportedNot reportedNot reportedNot reported
Month 6

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)1
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)88,100Not reportedNot reportedNot reportedNot reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)8,120Not reportedNot reportedNot reportedNot reported
Month 15

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)0
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)1
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)NANot reportedNot reportedNot reportedValues listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
Month 18

Analysis denominator · Participants

GroupSource count
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)0
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)1
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)0
Values in copies/1x10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)NANot reportedNot reportedNot reportedValues listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
        group Id
        OG000
        value
        NA
      2. comment
        Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
        group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Baseline (1 week prior to infusion)
  2. categories
    1. measurements
      1. comment
        Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
        group Id
        OG000
        value
        NA
      2. comment
        Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.
        group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Predose Day 0
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4,240,000
      2. group Id
        OG001
        lower Limit
        779,000
        upper Limit
        3,970,000
        value
        2,570,000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Post Dose Day 0
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3,190,000
      2. group Id
        OG001
        lower Limit
        20,700
        upper Limit
        1,710,000
        value
        59,200
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2,640,000
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        2,270,000
        value
        408,000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 2
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3,500,000
      2. group Id
        OG001
        lower Limit
        18,700
        upper Limit
        3,400,000
        value
        570,000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        743,000
      2. group Id
        OG001
        lower Limit
        5,320
        upper Limit
        3,730,000
        value
        101,000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 7
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        674,000
      2. group Id
        OG001
        lower Limit
        14,200
        upper Limit
        961,000
        value
        112,000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 10
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        984,000
      2. group Id
        OG001
        lower Limit
        7,900
        upper Limit
        938,000
        value
        112,000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 14
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        504,000
      2. group Id
        OG001
        lower Limit
        1,140
        upper Limit
        489,000
        value
        41,300
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 21
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        404,000
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        297,000
        value
        32,100
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 28
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        197,000
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        203,000
        value
        27,800
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Week 6
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Persistence of TCR-T cells in peripheral blood was assessed by quantitative PCR for vector copy number per 1 × 10⁶ cells at baseline (1 week prior to infusion), predose (Day 0), and multiple post-infusion time points through Month 18. Only quantifiable values are summarized. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" are reported as NA and excluded from summary statistics.
dispersion Type
Full Range
groups
  1. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
    id
    OG000
    title
    Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
  2. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
    id
    OG001
    title
    Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
  3. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
    id
    OG002
    title
    Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
param Type
MEDIAN
population Description
Persistence analyses included the 8 participants who received TCR-T infusion (1 at Dose Level 1 and 7 at Dose Level 2). A total of 14 participants underwent apheresis, but only infused participants were evaluable for persistence. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" were not quantifiable and are reported as NA. Participants without samples at a given time point were excluded.
reporting Status
POSTED
time Frame
Baseline through Month 18 post-infusion.
title
TCR-T Cell Persistence
type
SECONDARY
unit Of Measure
copies/1x10^6 cells

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Preserved source evidence · Not medical advice