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NCT05194735 · OUTCOME

Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)

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
NUMBER
Unit
Dose level of TCR-T cells infused
Interval / dispersion
Not reported
Time frame
From Day 0 to Day 28 post TCR-T cell drug product infusion.

What was measured

The MTD and/or RP2D was to be determined based on dose-limiting toxicities observed during the dose-escalation phase. The planned definition required ≥2 patients at a given dose level to experience a DLT to declare that dose not tolerated.

Analysis population: All participants who received a TCR-T infusion and were monitored for DLTs were included in a single analysis population. Eight participants were infused (6 at Dose Level 1, 2 at Dose Level 2). The MTD/RP2D could not be determined because the study closed early before enough evaluable participants were treated to allow formal determination.

Groups in this outcome

All Dose Levels (DLT-Evaluable Population)

Includes all participants who received a TCR-T cell infusion and were monitored for DLTs across all dose levels (6 participants at Dose Level 1 and 2 participants at Dose Level 2; total = 8).

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 Dose Levels (DLT-Evaluable Population)8

Reported measurements

Source class 1
Values in Dose level of TCR-T cells infused · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Dose Levels (DLT-Evaluable Population)NANot reportedNot reportedNot reportedThe MTD or RP2D could not be determined because the study closed early before sufficient participants were treated and evaluated for DLTs to allow formal determination.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The MTD or RP2D could not be determined because the study closed early before sufficient participants were treated and evaluated for DLTs to allow formal determination.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The MTD and/or RP2D was to be determined based on dose-limiting toxicities observed during the dose-escalation phase. The planned definition required ≥2 patients at a given dose level to experience a DLT to declare that dose not tolerated.
groups
  1. description
    Includes all participants who received a TCR-T cell infusion and were monitored for DLTs across all dose levels (6 participants at Dose Level 1 and 2 participants at Dose Level 2; total = 8).
    id
    OG000
    title
    All Dose Levels (DLT-Evaluable Population)
param Type
NUMBER
population Description
All participants who received a TCR-T infusion and were monitored for DLTs were included in a single analysis population. Eight participants were infused (6 at Dose Level 1, 2 at Dose Level 2). The MTD/RP2D could not be determined because the study closed early before enough evaluable participants were treated to allow formal determination.
reporting Status
POSTED
time Frame
From Day 0 to Day 28 post TCR-T cell drug product infusion.
title
Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)
type
PRIMARY
unit Of Measure
Dose level of TCR-T cells infused

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

Preserved source evidence · Not medical advice